ISGP 21st CB-SB - R and G PDF

Social science Engineering Framework
Institute on Science for Global Policy (ISGP)
Risk-benefit Media Public Synthetic Biology
Genetic Governance Regulation Voluntary
Anticipatory Databases Xenobiology
21st Century Borders/Synthetic Biology:

Focus on Responsibility and Governance
Conference convened by the ISGP Dec. 47, 2012

at the Hilton El Conquistador, Tucson, Arizona
Risk Technology Oversight Plants

Uncertainty Product Less-affluent countries
DIYBIO Biotechnology Emerging
Dynamic Environmental Government
Biosafety Self-regulation Nefarious
Genetically modified Protein Standards

Dual use Distribution Applications Food
21st Century Borders/Synthetic Biology:

Focus on Responsibility and Governance
Conference convened by the ISGP in partnership with

the University of Arizona at the Hilton El Conquistador Hotel
Tucson, Arizona, U.S.
Dec. 47, 2012
An ongoing series of dialogues and critical debates

examining the role of science and technology
in advancing effective domestic and international policy decisions
Tucson, AZ Office
845 N. Park Ave., 5th Floor
PO Box 210158-B
Tucson, AZ 85721
Washington, DC Office
818 Connecticut Ave. NW
Suite 800
Washington, DC 20006
www.scienceforglobalpolicy.org
Copyright Institute on Science for Global Policy, 2013. All rights reserved.
ISBN: 978-0-9803882-4-0
ii
Table of contents
Executive summary
Introduction: Institute on Science for Global Policy (ISGP) .............. 1
Dr. George H. Atkinson, Founder and Executive Director, ISGP,
and Professor Emeritus, University of Arizona
Conference conclusions:
Areas of consensus and Actionable next steps ...................................... 7
Conference program ........................................................................................... 11
Policy position papers and debate summaries
Synthetic Biology Do We Need New Regulatory Systems?

Prof. Paul Freemont, Centre for Synthetic Biology and Innovation,
Imperial College London, United Kingdom ........................................... 14
Renovating Governance Strategies for Synthetic Biology and
Other Dual-Use Technologies
Dr. Amy Smithson, James Martin Center for
Nonproliferation Studies, Monterey Institute of
International Studies, United States ........................................................ 25
The Challenges of Deploying Synthetic Biology Technologies

in Developing Countries
Dr. Maria Mercedes Roca, Zamorano University, Honduras ................. 35
The Challenge To Meet Global Need For Protein Sources

For Animal Production
Prof. Eliot Herman, School of Plant Sciences,
University of Arizona, United States ....................................................... 45
Safeguarding the Genetic Firewall with Xenobiology

Dr. Markus Schmidt, Biofaction KG, Austria ......................................... 55
Policy Innovation in Synthetic Biology Governance

Ms. Leili Fatehi, Humphrey School of Public Affairs,
University of Minnesota, United States ................................................... 66
Do-It-Yourself Biology: Reality and the Path Toward Innovation

Dr. Todd Kuiken, Science and Technology Innovation Program,
Woodrow Wilson International Center for Scholars, United States ...... 76
iii
Governance of Synthetic Biology
Dr. Robert Friedman, J. Craig Venter Institute, United States ............... 87
Acknowledgment ........................................................................................... 100
Appendix
Biographical information of scientific presenters .............................. 103
Biographical information of ISGP Board of Directors ...................... 107
Biographical information of ISGP staff .............................................. 111
iv
FOCUS ON RESPONSIBILITY AND GOVERNANCE 1
Introduction
Dr. George H. Atkinson
Founder and Executive Director, Institute on Science for Global Policy
and
Professor Emeritus, Department of Chemistry and Biochemistry and
College of Optical Sciences, University of Arizona
Preface
The contents of this book were taken from material presented at an international
conference convened by the Institute on Science for Global Policy (ISGP) on
December 47, 2012, in cooperation with the University of Arizona at the El
Conquistador Hotel and Resort in Tucson, Arizona. This ISGP conference was
part of the ISGP program on 21st Century Borders (21CB) and focused on Synthetic
Biology (SB).
The process underlying all ISGP conferences begins with the recognition that
a scientific topic such as SB has emerged on the international stage with advances
that promise immense opportunities to improve the human condition and also
simultaneously challenge many cultural, ethical, and economic issues throughout
societies worldwide. Decisions within societies concerning how to appropriately
incorporate such transformational science into public and private sector policies
rely on candid debates that highlight the credible options developed by scientific
communities throughout the world. Since SB can potentially have significant
impact across many different types of borders well beyond the geographical, it
deserves attention from both domestic and international policy makers from a
wide range of disciplines. ISGP conferences offer those rare environments where
such critical debates can occur among credible scientists, influential policy makers,
and societal stakeholders.
Based on extensive interviews conducted by the ISGP staff with an
international group of subject-matter experts, the ISGP invited eight highly
distinguished individuals with expertise in SB and the related aspects of the genomic
revolution to prepare the three-page policy position papers to be debated at the
Tucson conference. These eight policy position papers, together with the not-for-
attribution summaries of the debates of each paper, are presented in this book.
The areas of consensus and actionable next steps that were developed by all
participants in the caucuses that followed the debates are also presented. The debate
2 21ST CENTURY BORDERS/SYNTHETIC BIOLOGY
summaries and caucus results were written by the ISGP staff and are based on
contributions from the conference participants.
Current realities
While the material presented here is comprehensive and stands by itself, its policy
significance is best appreciated if viewed within the context of how domestic and
international science policies have been, and often currently are being, formulated
and implemented.
As the second decade of the 21st century opens, most societies are facing
difficult decisions concerning how to appropriately use, or reject, the dramatic
new opportunities offered by modern scientific advances and the technologies that
emanate from them. Advanced scientific research programs, as well as commercially
viable technologies, are now developed globally. As a consequence, many societal
issues related to science and technology (S&T) necessarily involve both domestic
and international policy decisions, both in the public and private sectors. The
daunting challenges to simultaneously recognize immediate technological
opportunities, while identifying those emerging and at-the-horizon S&T
achievements that foreshadow transformational advantages and risks within specific
societies, are now fundamental governmental responsibilities. These responsibilities
are especially complex since policy makers must consider the demands of different
segments of society, which often have conflicting goals. For example, decisions
must balance critical commercial interests that promote economic prosperity with
the cultural sensitivities that often determine if, and how, S&T can be successfully
integrated into any society.
Many of our most significant geopolitical policy and security issues are directly
connected with the remarkably rapid and profound S&T accomplishments of our
time. Consequently, it is increasingly important that the S&T and policy
communities (public and private) communicate effectively. With a seemingly
unlimited number of urgent S&T challenges, both wealthy and less-wealthy societies
need their most accomplished members to focus on effective, real-world solutions
relevant to their specific circumstances. Some of the most prominent challenges
involve (i) infectious diseases and pandemics, (ii) environmentally compatible
energy sources, (iii) the consequences of climate change, (iv) food safety, security,
and defense (v) the cultural impact of stem cell applications, (vi) nanotechnology
and human health, (vii) cyber security for advanced telecommunication, (viii) the
security implications of quantum computing, and (ix) the cultural radicalization
of societies.
Recent history suggests that most societies would benefit from improving
the effectiveness of how scientifically credible information is used to formulate
and implement governmental policies, both domestic and international.
Specifically, there is a critical need to have the relevant S&T information concisely
presented to policy communities in an environment that promotes candid questions
and debates led by those nonexperts directly engaged in decisions. Such discussions,
sequestered away from publicity, can help to clarify the advantages and potential
risks of realistic S&T options directly relevant to the challenges being faced.
Eventually, this same degree of understanding, confidence, and acknowledgment
of risk must be communicated to the public to obtain the broad societal support
needed to effectively implement any decision.
The ISGP mission

The ISGP has pioneered the development of a new type of international forum
based on a series of invitation-only conferences. These ISGP conferences are
designed to provide articulate, distinguished scientists and technologists
opportunities to concisely present their views of the credible S&T options available
for addressing major geopolitical and security issues. Over a two-year-plus period,
these ISGP conferences are convened on different aspects (e.g., synthetic biology)
of a broad, overarching topic (e.g., 21st Century Borders). Among the most
challenging S&T advances transcending many types of borders (e.g., geographical.
cultural, ethical, and political) are the diverse forms of the genomic revolution,
including those aspects related to the creation of living material via SB.
ISGP programs rely on the validity of two overarching principles:

1. Scientifically credible understanding must be closely linked to the realistic
policy decisions made by governmental and societal leaders in addressing
both the urgent and long-term challenges facing 21st century societies.
Effective decisions rely on strong domestic and global public endorsements
that motivate active support throughout societies.
2. Communication among scientific and policy communities requires
significant improvement, especially concerning decisions on whether to
use or reject the often transformational S&T opportunities continually
emerging from the global research communities. Effective decisions are
facilitated in venues where the advantages and risks of credible S&T
options are candidly presented and critically debated among
internationally distinguished subject-matter experts, policy makers, and
private sector and community stakeholders.
Historical perspective
The dramatic and rapid expansion of academic and private sector scientific research
transformed many societies of the 20th century and is a major factor in the
emergence of the more affluent countries that currently dominate the global
economic and security landscape. The positive influence of these S&T achievements
has been extremely impressive and in many ways the hallmark of the 20th century.
However, there have also been numerous negative consequences, some immediately
apparent and others appearing only recently. From both perspectives, it would be
difficult to argue that S&T has not been the prime factor defining the societies we
know today. Indeed, the 20th century can be viewed through the prism of how
societies decided to use the available scientific understanding and technological
expertise to structure themselves. Such decisions helped shape the respective
economic models, cultural priorities, and security commitments in these societies.
It remains to be seen how the prosperity and security of 21st century societies
will be shaped by the decisions made by our current leaders, especially with respect
to how these decisions reflect sound S&T understanding.
Given the critical importance of properly incorporating scientifically credible
information into major societal decisions, it is surprising that the process by which
this is achieved by the public and its political leadership has been uneven and,
occasionally, haphazard. In the worst cases, decisions have been based on
unrecognized misunderstanding, overhyped optimism, and/or limited respect for
potentially negative consequences. Retrospectively, while some of these outcomes
may be attributed to politically motivated priorities, the inability of S&T experts
to accurately communicate the advantages and potential risks of a given option
must also be acknowledged as equally important.
The new format pioneered by the ISGP in its programs seeks to facilitate
candid communication between scientific and policy communities in ways that
complement and support the efforts of others.
It is important to recognize that policy makers routinely seek a degree of
certainty in evaluating S&T-based options that is inconsistent with reality, while
S&T experts often overvalue the potentially positive aspects of their proposals.
Finite uncertainty is always part of advanced scientific thinking and all possible
positive outcomes in S&T proposals are rarely realized. Both points need to be
reflected in policy decisions. Eventually, the public needs to be given a frank,
accurate assessment of the potential advantages and foreseeable disadvantages
associated with these decisions. Such disclosures are essential to obtain the broad
public support required to effectively implement any major decision.
ISGP conference structure

At each ISGP conference, eight internationally recognized, subject-matter experts
are invited to prepare concise (three pages) policy position papers. For the
December 47, 2012, ISGP conference in Tucson, Arizona, these papers described
the authors views on current realities, scientifically credible opportunities and
associated risks, and policy issues concerning SB. These eight authors were chosen
to represent a broad cross section of viewpoints and international perspectives.
Several weeks before the conference convened, these policy position papers were
distributed to representatives from governments, societal organizations, and
international organizations engaged with the ISGP (the United States, Austria, Italy,
the United Kingdom, Australia, Canada, Honduras, the Republic of Korea, and
Germany). Individuals from several private sector and philanthropic organizations
also were invited to participate and, therefore, received the papers. All participants
had responsibilities and/or made major contributions to the formulation and
implementation of domestic and international policies related to SB.
The conference agenda was comprised of eight 90-minute sessions, each of
which was devoted to a debate of a given policy position paper. To encourage
frank discussions and critical debates, all ISGP conferences are conducted under
the Chatham House Rule (i.e., all the information can be used freely, but there can
be no attribution of any remark to any participant). In each session, the author
was given 5 minutes to summarize his or her views while the remaining 85 minutes
were opened to all participants, including other authors, for questions, comments,
and debate. The focus was on obtaining clarity of understanding among the
nonspecialists and identifying areas of consensus and actionable policy decisions
supported by scientifically credible information. With active participation from
North America, Australia, Europe, and Asia, these candid debates are designed to
reflect international perspectives on real-world problems.
The ISGP staff attended the debates of all eight policy position papers. The
not-for-attribution summaries of each debate, prepared from their collective notes,
are presented here immediately following each policy position paper. These
summaries represent the ISGPs best effort to accurately capture the comments
and questions made by the participants, including the other authors, as well as
those responses made by the author of the paper. The views expressed in these
summaries do not necessarily represent the views of a specific author, as evidenced
by his or her respective policy position paper. Rather, the summaries are, and
should be read as, an overview of the areas of agreement and disagreement that
emerged from all those participating in the debates.
Following the eight debates, caucuses were held by small groups each
representing a cross section of the participants. A separate caucus for the scientific
presenters also was held. These caucuses focused on identifying areas of consensus
and actionable next steps for consideration within governments and civil societies
in general. Subsequently, a plenary caucus was convened for all participants. While
the debates focused on specific issues and recommendations raised in each policy
position paper, the caucuses focused on overarching views and conclusions that
could have policy relevance both domestically and internationally.
A summary of the overall areas of consensus and actionable next steps
emerging from these caucuses is presented here immediately following this
introduction under the title of Conference conclusions.
Concluding remarks
ISGP conferences are designed to provide new and unusual (perhaps unique)
environments that facilitate and encourage candid debate of the credible S&T
options vital to successfully address many of the most significant challenges facing
21st century societies. ISGP debates test the views of subject-matter experts through
critical questions and comments from an international group of decision makers
committed to finding effective, real-world solutions. Obviously, ISGP conferences
build on the authoritative reports and expertise expressed by many domestic and
international organizations already actively devoted to this task. As a not-for-profit
organization, the ISGP has no opinions nor does it lobby for any issue except rational
thinking. Members of the ISGP staff do not express any independent views on
these topics. Rather, ISGP programs focus on fostering environments that can
significantly improve the communication of ideas and recommendations, many
of which are in reports developed by other organizations and institutes, to the
policy communities responsible for serving their constituents.
ISGP conferences begin with concise descriptions of scientifically credible
options provided by those experienced in the S&T subject, but rely heavily on the
willingness of nonspecialists in government, academe, foundations, and the private
sector to critically debate these S&T concepts and proposals. Overall, ISGP
conferences seek to provide a new type of venue in which S&T expertise not only
informs the nonspecialists, but also in which the debates and caucuses identify
realistic policy options for serious consideration by governments and societal
leaders. ISGP programs are designed to help ensure that S&T understanding is
integrated into those real-world policy decisions needed to foster safer and more
prosperous 21st century societies.
Conference conclusions
Area of Consensus 1:
As a continuum of remarkable advances in biotechnology appearing in recent
decades, there are immediate and long-term positive and negative impacts of
synthetic biology having implications well beyond the life sciences. Given the
potential for misuse of such a dual-use technology, academic and private-sector
practitioners of synthetic biology, as well as those involved in providing oversight,
have the responsibility to minimize security risks, while ensuring that potential
benefits are realized.
Actionable Next Steps

Foster a culture of responsibility in which all practitioners, public,
academic, and private, are appropriately trained in biosafety best practices
and that their expertise is widely shared (e.g., recommendations and
nonproliferation mechanisms from the National Science Advisory Board
for Biosecurity [NSABB]).
Continue to strengthen the engagement between law enforcement and
synthetic biology communities to promote awareness of dual use, security,
and safety issues.
Utilize approaches such as modeling, gaming, and information sharing
to identify possible positive and negative impacts of synthetic biology, as
well as gaps in current safety and security mechanisms.
Promote the adoption of lifecycle management practices for
biotechnology facilities to safeguard against the misuse of retired
equipment.
Synthetic biology has the potential to substantially impact food and agriculture
practices locally, regionally, and globally. Contributions to agricultural
biotechnology are currently limited to a small number of large private sector
companies because of the cost of regulatory approval. As a result, the current
focus has been on areas of commercial benefit, such as insect and herbicide
resistance. Synthetic biology enables scientists to focus on other important societal

goals, such as broader environmental tolerance of crops (e.g., drought tolerance
and marginal water availability), lower input costs (e.g., increasing efficiency of
nitrogen use), and increased nutritional quality (e.g., better amino acid balance,
and micronutrients).

Streamline the regulatory evaluation processes for agricultural
biotechnology products (e.g., introducing a single assessment by a joint,
interagency committee in the U.S.).
Broaden the focus of research and development in agricultural synthetic
biology from introducing traits that primarily benefit large private
companies (e.g., insect and herbicide resistance) to those that benefit a
wider group of producers and consumers (e.g., better environmental
tolerance, lower input costs, and increased nutritional quality).
Build the capacity of less-affluent countries to utilize synthetic biology
for the development of products that improve food security and economic
advancement in those countries.
While the interests, aspirations, and risk/benefit ratios vary by society and are best
understood by individuals in a specific population, synthetic biology is a potentially
powerful economic driver. Rather than focusing on exporting synthetic biology
technologies, more-affluent countries need to focus on capacity building including
efforts to promote technologies that offer benefits in less-affluent communities

Expand availability of university resources found in more-affluent
countries for a variety of programs (e.g., through Massively Open Online
Courses, collaborative research and development, building local capacity
through access to state-of-the-art synthetic biology techniques, personnel
exchange programs, and seed money and mentoring for educational
programs such as the iGEM competition).
Develop more balanced intellectual property systems that protect the
rights of technology developers without unduly restricting the accessibility
of less-affluent countries to synthetic biology technologies developed
elsewhere.
Establish international forums for articulating the concerns of less-affluent

countries concerning policies developed elsewhere.
Since governance systems concerning synthetic biology are complex and cover a
wide spectrum of societal needs, they require innovative and dynamic approaches,
including policies for academic research, product development, environmental
release and product deployment, acceptable dual-use characteristics, identification,
and resolution of misuse. Such governance policies encompass issues concerning
self-governance, best practices, enforcement guidelines, regulations, and legal
procedures, which influence transparency, disclosure, and accountability.

Assess current best practices worldwide and identify existing gaps prior
to the development of new governance frameworks for synthetic biology
(e.g., through the appointment of an expert commission using
multidisciplinary stakeholders).
Empower regulatory agencies to review synthetic biology products in a
timely manner (e.g., via funding, clear agency responsibilities, and
streamlined approval processes).
Expand access to existing facilities (e.g., community colleges) to serve
the interests of the Do-It-Yourself Biology (DIYBIO) community and to
improve the oversight and management of DIYBIO activities.
The broad acceptance of synthetic biology activities, products, and governance
needed to support innovative policies requires extensive public dialogue and
understanding of credible information based on an effective communication
strategy. Since stakeholders in synthetic biology (e.g., the DIYBIO community,
private sector biotechnology companies, and academic researchers) vary greatly in
their professional expertise, promoting broad-based support is critical to the
implementation of effective public policy.

Develop and implement strategies for the public based on the credible
understanding that biotechnologies derived from synthetic biological
methods are not inherently more risky than those introduced by

conventional methods. The development of such strategies much involve
multidisciplinary academic, private sector, and DIY teams.
Synthetic biology practitioners need concentrated and sustained
engagement with legislators and policy makers to discuss and clarify the
risks and benefits of synthetic biology for economic prosperity, and
protection of human and environmental welfare.
Harness the educational potential of DIYBIO, performed safely and
responsibly, to engage the public, and young people in particular, in
promoting the beneficial impact of synthetic biology.
ISGP conference program

Tuesday, December 4
12:00 17:00 Arrival and Registration: Hilton El Conquistador
16:00 17:00 Conference Meeting: Science presenters
17:00 18:00 Caucus Meeting: All presenters and participants
18:00 19:00 Reception
19:00 19:10 Welcoming Remarks
Dr. George Atkinson, Institute on Science for Global Policy
(ISGP) Founder and Executive Director
19:00 20:30 Dinner
Wednesday, December 5
07:00 08:45 Breakfast
09:00 09:10 Welcoming Remarks
Dr. Eugene Sander, 20th President, University of Arizona
Presentations and Debates: Session 1

09:00 10:40 Prof. Paul Freemont, Centre for Synthetic Biology
and Innovation, Imperial College London, United Kingdom
Synthetic Biology DoWe Need New Regulatory Systems?
10:40 11:00 Break
11:00 12:30 Dr. Amy Smithson, James Martin Center for
Nonproliferation Studies, Monterey Institute of
International Studies, United States
Renovating Governance Strategies for Synthetic Biology
and Other Dual-Use Technologies
12:30 14:30 Lunch and presentations by University of Arizona scientists
14:30 16:00 Dr. Maria Mercedes Roca, Zamorano University, Honduras
The Challenges of Deploying Synthetic Biology Technologies
in Developing Countries
16:00 16:30 Break
16:30 18:00 Prof. Eliot Herman, School of Plant Sciences,

University of Arizona, United States
The Challenge To Meet Global Need For Protein Sources
For Animal Production
18:30 19:30 Reception
19:30 20:30 Dinner
20:30 21:00 Evening Remarks
Dr. Drew Endy, Assistant Professor of Bioengineering,
Stanford University
Thursday, December 6
09:00 10:30 Dr. Markus Schmidt, Biofaction KG, Austria
Safeguarding the Genetic Firewall with Xenobiology
10:30 11:00 Break
11:00 12:30 Ms. Leili Fatehi, Humphrey School of Public
Affairs, University of Minnesota, United States
Policy Innovation in Synthetic Biology Governance
12:30 14:00 Lunch
14:00 15:30 Dr. Todd Kuiken, Science and Technology Innovation
Program, Woodrow Wilson International Center
for Scholars, United States
Do-It-Yourself Biology: Reality and the Path Toward
Innovation
15:30 16:00 Break
16:00 17:30 Dr. Robert Friedman, J. Craig Venter Institute,
United States
Governance of Synthetic Biology
Caucuses
17:30 22:00 Focused group sessions
Friday, December 7
09:00 12:10 Plenary Caucus Session
Dr. George Atkinson, moderator
12:10 12:30 Closing Remarks, discussion of ISGP conferences 20132014
Dr. George Atkinson
12:30 13:30 Lunch
13:30 Adjournment
Synthetic Biology Do We Need New

Regulatory Systems?**
Paul Freemont, Ph.D.
Co-director, Centre for Synthetic Biology and Innovation,
Division of Molecular Biosciences, Imperial College London,
London, United Kingdom
Summary
Synthetic biology (SB) is a new interdisciplinary field that aims to establish a
systematic framework for the engineering of biological systems and cells to both
address fundamental questions and provide new applications. The potential
economic promise of SB is such that numerous countries are developing strategies
for establishing SB in both academia and industry. Part of these strategies is the
early inclusion of social scientists and policy makers, although there remains
uncertainty as to how rapidly the field will develop and to what scale. Given that
chromosome synthesis and assembly are now technically feasible, are new national
and international regulatory and governance structures required? Can current
and future SB research be accommodated within existing genetic modification
(GM) regulatory systems and is self-regulation a suitable modus operandi for SB?
Current realities
Synthetic biology has been rapidly growing as a new research discipline since the
early 2000s. However, while it is widely accepted by many researchers, funders,
and policy makers that SB as a multidisciplinary approach aims to make the
engineering of biological systems easier, there still remains confusion as to why
this field has emerged now, despite enabling engineering work that has been ongoing
for the past 20 to 30 years. The major drivers for the emergence of SB are the
availability of complete genome sequences enabled by low-cost DNA sequencing,
advances in bioinformatics, data mining and modeling, and the rapid development
of cheap chemical synthesis of DNA. All of these strands now come together, which
when combined with the development of an engineering framework, allows
researchers to start thinking about designing biological systems and genetic circuits
much like an engineer designs new electronic circuit boards. This powerful analogy
results in complex biological systems being broken down into an engineering-like
hierarchy of parts, devices, and systems where DNA forms the parts (termed
bioparts or biobricks) that when combined give rise to biological devices that
together form biological systems. Current realities, however, do not allow such
smooth transitions between the different hierarchies. For example, designing a
biological system at the DNA sequence level does not guarantee that such a
constructed system will perform as predicted in a living cell. This remains one of
the key challenges of SB, although the rapid development of foundation
technologies and frameworks for systematically engineering cells may allow this
vision to become a partial reality in the next few years. One notable new project
that illustrates this is the international consortium led by Jef Boeke of Johns Hopkins
University to build the first synthetic genome for the budding yeast Saccharomyces
cerevisiae. The project brings together international, public-funded researchers
from the United States, China, India, and the United Kingdom, based on open-
source and sharing of results, similar to the publicly funded human genome project.
The success of the project will not only provide researchers with tools to study
yeast biology but also provide a host cell that can be easily engineered using SB
approaches for specific applications.
The current environment to achieve such a vision is formed from a number
of important strands. First, a developing SB academic community is emerging,
driven in part by the continuing success of the International Genetically Engineered
Machine (iGEM) undergraduate student competition. Second, government
funding agencies around the world are targeting SB research for significant
investment with the increasing realization that, as an application-driven field, there
may be significant economic benefits to be realized. Third, higher education
institutes have responded to the new field by creating interdisciplinary teaching
and research programs in SB. Finally, biotechnology, energy, and pharmaceutical
industries are exploring how SB could accelerate their existing product pipelines
as well as research and development. There is also an expanding and energized
start-up culture in SB driven in part by iGEM and the youthful nature of the
field. In summary, the current reality is that we are at the early stage of an exciting
and developing interdisciplinary application-driven field that aims to establish a
legitimate engineering framework for biological engineering based in part on an
open-source philosophy and the energy of youthfulness and optimism.
Scientific opportunities and challenges

Opportunities: The application areas that have been linked to potential SB solutions
include energy and fuels, greener production of commodity chemicals, biomaterials
(e.g., spider silk or bacterial cellulose), specialty chemicals and pharmaceuticals,
protein-based bioproducts (e.g., enzymes), medical applications (e.g., biosensors,

smart therapeutics, and tissue engineering), bioremediation solutions for pollution,
biomining to increase yields from mineral ores using biological organisms, and
engineering crops and soil organisms to increase global food yields. Although
many of these opportunities have not yet been realized, by applying a systematic
engineering approach to biological design, a series of platform technologies is
emerging that will enable many different applications in the short and long term.
Examples include new, efficient methods for rapid combinatorial DNA assembly;
the rapid characterization of biological parts libraries and specific host cells (chassis)
for SB; and the integration of modeling and computer-aided design (bioCAD) to
aid biological design in silico. These platform technologies will inevitably lead to
standardization as part of the field of SB that will accelerate the uptake of the
technology both in academia and industry.
Technical challenges: As stated above, SB aims to apply engineering principles to
biological systems but there are significant technical challenges to achieving this.
For synthetic biologists, it is important to realize that although living cells are not
electronic circuit boards, they do utilize many regulatory elements in their decision-
making processes which mimic the behavior of human-defined electronic
components (e.g., genetic switches that act as logic-like inverters), but at a biological
time scale of seconds to minutes. Cells can also use sensors (e.g., small molecule
inducers) to activate transcription of specific genes or environmental sensors (e.g.,
light) that activate specific gene networks or cell-cell communications systems that
signal between cells. Cells are thus exquisitely evolved to sense and adapt to their
living environments and have genetic circuits that encode these functions. It is
these circuits that synthetic biologists are now adapting for different applications
As we begin to fully understand the function of single cells at a systems level though
experimental and mathematical modeling (which is the aim of systems biology),
our ability to predictably intervene in such systems will be significantly increased.
It is important to note that similar situations exist in other fields of engineering,
such as with semiconductors (e.g., transistors), where physicists and engineers have
worked for many years to obtain optimal performance. It is also interesting to
consider naturally occurring DNA-encoded functional modules like bacterial
operons, where biological context and complexity have been already encoded within
the DNA sequence through evolution. The challenge here is to correctly interface
such modules, which again requires a systematic approach.
Societal challenges: One interesting aspect about the developing field of SB has
been the early engagement and exchange among social scientists, scientists, and
engineers. The cynical view is that synthetic biologists are trying to prevent an
unfavorable public reaction to their work and thus by engaging with social scientists,
they can somehow achieve a level of acceptability through professional scrutiny.
This is a very simplistic and incorrect view and a more realistic assessment is that
SB is a research field that requires and encompasses the interdisciplinary work of
social scientists. It is perhaps obvious that to create a vision of engineering biology
based on SB, the final outcomes will rightly be open to public questioning.
Policy issues
Although humans have been carrying out genetic manipulations for
centuries through selective breeding, and more recently through modern
molecular biology techniques, it is clear that the scale and vision of SB
require a reassessment of the public value. Much progress has been made
in public dialogues around SB primarily in the U.S. and U.K., and these
activities need to continue, perhaps with even greater vigor and
responsiveness. It is important to note that at least in the U.K., all publicly
funded researchers in SB must have social scientists as collaborators and
co-investigators on any SB project. The overall aim is to integrate social
scientists and scientists/engineers at the early stage of project development
and the term responsible research innovation used to describe this is
being discussed widely. If society in general does not see any real and/or
tangible benefit to the adoption of SB technologies, then the field will be
in real danger of fizzling out before it has started.
SB poses a number of key policy issues around regulation and governance,
in particular whether existing international regulations are sufficient to
govern this emerging field or whether new policies and/or structures are
needed. This is a difficult question, as any newly emerging technology
with transformative potential has by inference some unknown outcomes.
The main issue is whether national and international regulatory structures
currently in place are sufficient to govern access to DNA synthesis
capabilities, encompass large-scale genome engineering, monitor the
environmental release of synthetically engineered organisms, and oversee
the synthesis and potential design of human chromosomes.
In relation to the U.K., there are already significant GM regulations in
place that cover most of the current SB research within contained
laboratory facilities. The regulations are implemented locally as part of a
government licensing system, with every GM and/or experiment using
biological material formally registered (locally) and approved before

commencement. The formal registration form covers areas such as Risks
and Control Measures, Personal Protective Equipment and Hygiene,
Waste, Maintenance, Training, Emergency Procedures, Access,
Occupational Health, Containment Level, and GM class. In terms of GM
release, another rigorous set of regulations is already in place, with each
project requiring, in effect, government approval.
Whilst I feel that the U.K. system has the right balance of regulation
(although under continual review), I am concerned that the scale, scope,
and potential of SB internationally leads to the need for global forums,
agreements, and perhaps even governance standards for SB. This should
not only include government-funded research and companies (often
global), but also public activities like do-it-yourself biology and service
provider companies (e.g., DNA synthesis). Such forums should also
include all stakeholders and be transparent at all levels. I would argue
that because SB is at an early stage of development but rapidly growing
and evolving, there is an urgent need to develop international forums,
which can also evolve and change as the field develops.
** A policy position paper prepared for presentation at the conference on 21st Century
Borders/Synthetic Biology: Focus on Responsibility & Governance, convened by the Institute
on Science for Global Policy (ISGP) Dec. 47, 2012, at the Hilton El Conquistador,
Tucson, Arizona
Debate Summary
The following summary is based on notes recorded by the ISGP staff during the
not-for-attribution debate of the policy position paper prepared by Prof. Paul
Freemont (see above). Prof. Freemont initiated the debate with a 5-minute
statement of his views and then actively engaged the conference participants,
including other authors, throughout the remainder of the 90-minute period.
This Debate Summary represents the ISGPs best effort to accurately capture
the comments offered and questions posed by all participants, as well as those
responses made by Prof. Freemont. Given the not-for-attribution format of the
debate, the views comprising this summary do not necessarily represent the
views of Prof. Freemont, as evidenced by his policy position paper. Rather, it is,
and should be read as, an overview of the areas of agreement and disagreement
that emerged from all those participating in the critical debate.
Debate conclusions
Because the definition of synthetic biology is contested, ranging from it
being a new emerging engineering discipline to a continuation of
biotechnology, it is not clear whether synthetic biology can be covered by
existing regulation and oversight mechanisms, or requires new measures.
However, any new measures must remain adaptable to the many changes
anticipated as the technology advances.
Although the inclusion of social scientists in synthetic biology research is
widely supported, the question remains as to how much such
collaboration should influence the field. In general, younger generations
of synthetic biology researchers view collaboration with other disciplines
as the norm.
While educational curricula in synthetic biology education in some
countries include social sciences, their inclusion require consideration of
differing cultures its impact on establishing a single set of educational
requirements. Diversity of values in varying populations must also be
considered in regard to setting up an infrastructure conducive to two-
way dialogue.
To avoid adverse public responses to synthetic biology, there is a need to
democratize the science through greater public engagement in
governance based on communicating credible scientific understanding.
Current realities
Debates regarding the classification of synthetic biology largely centered on whether
synthetic biology should be defined as a new engineering field, as opposed to simply
an advance in the existing field of biotechnology. Those who consider synthetic
biology a new engineering field argued that synthetic biology brings concepts and
designs at molecular and cellular levels that have not previously existed in
biotechnology, and which are distinctly different from biotechnology products
derived from metabolic engineering. Within the engineering paradigm, synthetic
biology is a new and emerging field and there is still much to learn from engineering
design processes and engineering production in regard to quality management
and safety. As the field develops, questions of standardization (e.g., what is a
standard and what are its limitations?) are emerging as increasingly important issues.
Because advances in engineering generally have benefited from the
involvement of social scientists and since synthetic biology (e.g., the building of
genomes) is viewed as an advance in engineering, similar involvement of social
scientists could be equally as beneficial. This was exemplified by the yeast synthetic
genome project, which aims to produce the first synthetic eukaryotic cell in
approximately 2017. The issues that are anticipated to arise from the yeast synthetic
genome project were asserted to require interactions with social scientists. This
was believed to be particularly relevant in the U.K., where involving social scientists
in advancing the field of synthetic biology has proven necessary given historical
anti-gene modification sentiment. However, it was cautioned that mandating
involvement of social scientists, or dictating the type of involvement, could be
counterproductive with regard to public opinion.
Alternatively, the argument was made that synthetic biology is a new science,
at a very early stage of development, akin to the field of electronics in the 1940s.
Like nuclear fission before it, synthetic biology has dual-use properties that need
to be considered. The technology was described as having the potential to accelerate
quickly, through improvements in DNA sequencing and synthesis, which also made
the case for bringing an engineering framework into biology.
Efforts have been made to embed the importance of interdisciplinary research
in younger generations as an important part of synthetic biology research design.
At some institutions in the U.K., social science lectures are included in the
undergraduate course curriculum for synthetic biology studies, though it was noted
that this has not been an easy undertaking.
The role of the media in relation to public education was acknowledged. In
the U.K., although the media is unregulated and makes an important contribution
to democracy, it was often viewed as engaging in sensationalist reporting. More
scientifically accurate reporting in the U.K. is improving through initiatives such
as the Science Media Center, which aims to counterbalance sensationalism by giving
journalists access to scientifically credible sources of information.
Public engagement and transparency were also discussed via the example of
the public perception of salmon in Panama that has been genetically modified to
grow twice as fast as ordinary farmed salmon. While statutory constraints exist on
how much regulators may interact with the public, the importance of transparency
was emphasized. The U.S. Food and Drug Administration (FDA), which is
committed to be as transparent as possible, released a draft environmental
assessment on genetically modified salmon, including data on biological and
physical containment, for public comment before any formal approval was made.
In the U.K., funding agencies were viewed as being serious about public
engagement, with publicly funded researchers in the U.K. expected to be able to
discuss their work openly with the public. While scientists as communicators can
be both good and bad, publicly funded scientists have extra pressure to
communicate well.
Calls for the democratization of science stem from failures in
communication following crises such as the introduction of genetically modified
organisms (GMOs) and the response to bovine spongiform encephalopathy (BSE).
These communication failures were not attributed to a lack of information being
provided to the public, but rather to lack of effort in understanding the implications
of regulatory and/or institutional distrust among the public. In addition, an
experiment conducted in the U.K. in which randomly selected community members
were included as part of scientific funding panels, found their judgments correlated
to self-interest, which was seen as evidence of the limitations of including the public
in decision-making about scientific applications.
Invoking the precautionary principle by different countries in the European
Union was generally agreed to inhibit GM technology. In addition to the U.K., the
E.U. was seen as quick to overregulate, as evidenced by its response to genetically
engineered crops. In the U.S., regulators reviewed the risks and allowed gradual
deployment of GM crops, but because of the precautionary principle utilized in
Europe, those same products are only now being approved. The U.S. risk assessment
process, described as adequate and rigorous, was not applied in Europe and
therefore, resulted in delaying consumer choices and to some resulted in economic
harm. This was illustrated by the fact that the current bulk of synthetic biology
work is happening in countries where the precautionary principle is not invoked.

Rather than determining regulatory frameworks far in advance of the technologies
themselves, the challenge is to consider how to build a robust structure of regulations
that can evolve in a way that is simultaneously democratically accountable and
scientifically productive. While it was suggested that a dynamic style of innovative
regulation by government for be promoted, there was disagreement as to whether
traditional molecular biology and synthetic biology can be treated in the same
way.
From the perspective that synthetic biology is a new engineering field, it was
argued that synthetic biology provides a new framework to allow genetic
engineering to be done systematically and through protocols that can be shared.
This framework allows an open, noncompetitive, and innovative atmosphere for
companies to potentially find economically productive opportunities.
While it was generally agreed that opportunities for social scientists to be
more involved in synthetic biology projects need to be fostered, there was dissent
concerning how to extend such involvement to a societal, legal, or ethical issues

that tax government-funded programs. To prevent the requirement of public
impact studies from hampering advances in synthetic biology, the two activities
could be funded separately. However, it was contended that including social
scientists would help the field of synthetic biology progress. In many settings, the
collaboration between social scientists and lab scientists has proven useful, and
younger generations of synthetic biologists view the interaction as a natural part
of the development of the field.
Alternatively, social scientists could be engaged as appropriate, rather than
in a prescribed way. For example, if basic science was being conducted with the
understanding that it would be applied to making a food source, then relevant
food safety experts, economists, and social scientists should be consulted at the
start of the project to understand issues related to eventual acceptance of such
food products. However, if basic science was being conducted for the purpose of
answering a fundamental physiological question, then it would perhaps not be
necessary to involve social scientists at all. Those who advocated early collaborations
with social scientists in the research lifecycle described the need to understand the
impact on society from an early stage in the research. The purpose is to have those
doing the research engaged in social issues as part of the research process and as
part of the wider discipline. The success of this type of collaboration remains
uncertain. No firm conclusions were reached regarding the extent, and at what
stage of research, social scientists should be involved in the field of synthetic biology.
The public has increasingly become aware of failures in traditionally trusted
institutions in the wake of previous crises having negative outcomes. A current
challenge being faced is how to communicate with the public in the wake of previous
crises. Different democratic institutions have an opportunity to prevent similar
communication failures through an emphasis on two-way dialogue. Such an
opportunity exists primarily for the FDA, given its role as the most recognized
regulatory authority by the public in the U.S. It was generally agreed that the FDA
has done a masterful job over the last century of navigating the often-conflicting
expectations of industrial stakeholders and the expectations of the public. This
has allowed the FDA to effectively maintain a reputation that the public trusts, and
thereby it has been delegated authority by the public. Consequently, the FDA is
well positioned to consider emerging risks, yet still encouraging environments for
innovation.
Policy issues
Governance over the lifecycle of a technology may be better referred to as oversight
rather than regulation. Regulation implies a statutory responsibility and authority
that can both be expansive and restrictive to innovation. Therefore, considering
the range of bodies able to conduct oversight (i.e., international, federal, local, and
professional organizations, and their overlapping responsibilities), more effective
approaches to minimize regulation and focus on oversight activities of the daily
development of the technology. The aim of such oversight would be to implement
the delicate balance between encouraging new technologies and protecting the
public interests.
The point was made that the distinction between regulation and oversight
needs to be nuanced and could be denoted as adaptive management or
anticipatory governance (i.e., having the ability to adapt and change as necessary).
Research from Columbia University has investigated this idea of experimentation
in governance, using a variety of mechanisms. Regulation alone was thought to be
unable to keep pace with advances in modern technology. Traditional government
mandates, such as regulation, are one part of a complex regulatory strategy that
involves other forms of governance (e.g., codes of conduct and supply chain
management issues). Involving all relevant stakeholders to consider the variety of
governance tools and approaches within the context of a specific social culture was
generally agreed to be an appropriate way to implement effective risk management.
Regulation of synthetic biology was described as the ability for scientists to
actively engage in research within a harmonized framework. Because individuals
or organizations conducting unregulated genetic modification experiments (e.g.,
do-it-yourself biology) operate beyond the required regulations, it was argued that
risk assessments needed to be performed by focusing on identifying proper
regulatory frameworks that protect, but do not inhibit productive innovation.
The framework for regulating environmental release of modified microbes,
bacteria, or viruses requires special attention. There was a strong advocacy in the
U.K., due to an environmental lobby that continuously challenges the development
of genetically modified technologies, for balanced regulation. Such broach public
attention requires policies that promote research and innovation while anticipating
future technological developments.
A strong case was also made for ensuring that social scientists (e.g., behavioral
scientists, ethicists) are involved in the earliest stages of synthetic biology projects,
including the preparation of grant proposals. Their inclusion would bring a
different perspective that could provoke, critique, and negate ideas in constructive
ways. Identifying social scientists with the correct expertise as part of a bottom-up
process was recommended. Embedding social scientists in synthetic biology
programs, and proactively teaching the next generation of scientists the importance
of this inclusion, needs to be promoted as best practices in synthetic biology centers
around the world. Additionally, once social scientists are embedded within synthetic
biology research groups, they can be utilized to help address public concerns
through improved communication. Journalism students could also be invited to
participate in designing communication strategies that will avoid public
misunderstandings and potential mistrust of the science.
In addition to existing international forums, a new type of international forum
was proposed, which would bring together researchers and policy makers from
around the world to address different cultural views on synthetic biology. This
would be a valuable venue to share differing international views and build on best
practices. Whether such forums could be incorporated into existing international
organizations or would require a new organizational structure altogether remains
to be clarified.
It was argued that a wide range of stakeholders must be engaged in policy-
making processes to ensure that a broader community of thought is considered
before products enter the market. A continual review process is necessary because
of the uncertainty associated with the development of the field and the types of
products produced. Two-way dialogue requires ensuring that the correct
infrastructure is in place for effective cross-communication. Cultural considerations
will prove crucial in developing the appropriate forums for this type of interaction.
Synthetic biology was considered a part of the continuum of biomedical life
sciences and a large amount of work needs to be directed toward public education,
concerning an understanding of the basic science and an appreciation of both the
potential benefits and risks. However, the point was made that cultural and societal
differences play a part in the acceptance of various sciences (e.g., genetic
modification viewed as a more important issue in the U.K. than in the U.S.) and
the diversity of values in varying populations must be considered before any policies
are implemented across a culturally diverse region.
Renovating Governance Strategies for Synthetic Biology

and Other Dual-Use Technologies**
Amy E. Smithson, Ph.D.
Senior Fellow, James Martin Center for Nonproliferation Studies,
Monterey Institute of International Studies, Washington, D.C., United States
Summary
The life sciences offer tremendous societal benefits and are diffusing worldwide,
but this scientific revolution carries potentially devastating risks. Synthetic biology
has opened the door to de novo assembly of appalling contemporary pathogens
and those responsible for eradicated diseases, such as smallpox, while other vanguard
life sciences technologies could be hijacked to manipulate the human immune,
nervous, and endocrine systems. Some gene synthesis companies have voluntarily
taken steps to prevent the rogue assembly of dangerous pathogens by screening
customers and orders for genes. Similarly, after the September 11, 2001, attacks,
the Federal Bureau of Investigation (FBI) forged a public-private screening
partnership with manufacturers of various dual-use goods and services that could
be diverted from legitimate purposes to cause harm, a quietly effective tool in efforts
to disrupt and prosecute terrorist and criminal activities. Government and
academia, respectively the traditional guarantors of national security and fountains
of innovation, will be hard-pressed to keep pace with the life sciences revolution
and fashion new governance approaches. If industry more fully enters the
nonproliferation fray, society will have better leverage to keep one step ahead of
the bad guys.
Current realities
Assuring the security of a state is traditionally a government responsibility, one
that justifies armed forces, the cultivation of trading partners, military alliances,
intelligence, diplomacy, and the negotiation of treaties to draw behavioral
boundaries and cement common interests. Industrys customary role vis--vis
security is to supply material to a states armed services or to comply with regulations
on the manufacture and sale of product(s), including the declaration of activities
deemed pertinent to treaty-controlled weapons systems, such as the production of
chemicals that are precursors to warfare agents, and the acceptance of inspections
to ascertain treaty compliance. Individual governments can also stipulate the review
and licensing of weapons-critical products before sales to countries of proliferation
concern. In addition, major supplier nations have harmonized export controls on
numerous items via the Australia Group, the Nuclear Suppliers Group, and the
Missile Technology Control Regime. Thus, for the most part, industry is reactive
when it comes to nonproliferation.
Decades ago, the pace of discovery in the life sciences began ramping up
with the emergence of molecular biology, cell biology, and genomics. The discovery
rate turned revolutionary with the convergence of life sciences, engineering, the
physical sciences, and information technology, giving rise to entirely new disciplines,
including synthetic biology. With promising new applications in health, energy,
agriculture, and the environment that will elevate the quality of life and drive
economies, the life sciences are diffusing worldwide. Nations with flourishing
biotechnology industries or that are laying the foundation to become biological
powerhouses include Brazil, China, Cuba, Egypt, India, Mexico, Russia, Singapore,
South Korea, and Taiwan. Furthermore, automated equipment that de-skills
previously labor-intensive techniques and processes is enabling those with
rudimentary science know-how to perform advanced life sciences work. These
circumstances expose serious vulnerabilities in traditional government-designed
nonproliferation tools.
Following in the footsteps of the military, which of necessity became a path-
breaker in technology and societal change, large companies have also taken on
unanticipated roles as they expanded operations across multiple borders.
Accordingly, in 2010, the International Standardization Organization issued ISO
standard 26000, which lists six pillars of corporate responsibility: consumer issues,
fair operating practices, the environment, labor practices, human rights, and
community involvement and development.

The benefits of the life sciences aside, panels of distinguished scientists have
recognized the challenge of preventing the abuse of vanguard life sciences
technologies, such as RNA interference and nanobiotechnology. To illustrate,
malicious actors could combine sophisticated targeted-delivery technologies with
bioregulators to manipulate the human immune, nervous, and endocrine systems.
Synthetic biologists have artificially created the polio and 1918 influenza viruses,
which crippled and killed tens of millions in the 20th Century, and recovered
Marburg, a hemorrhagic fever virus, from a full-length cDNA clone. In 2010,
scientists required 1,080,000 base pairs, which cost a few dollars apiece, to generate
the Mycomplasma genome de novo. Variola major, the virus that causes smallpox,
has a comparatively modest number (186,102) of base pairs, which can be purchased
for a few dollars apiece. Synthetic biology has opened the door to the assembly
from scratch of appalling contemporary pathogens as well as those responsible for
eradicated diseases. Such factors prompted geneticist and molecular biologist
Matthew Meselson to warn in 2000 that, in the hands of those with malevolent
intent, new life sciences knowledge and technologies present unprecedented
opportunities for violence, coercion, repression, or subjugation.
Responding to the potential misuse of synthetic biology, the companies of
the International Association of Synthetic Biology and the International Gene
Synthesis Consortium have voluntarily fashioned safeguards to prevent the rogue
assembly of dangerous pathogens. They are screening orders for genes to ensure
they will not add up to something dangerous like anthrax, and they are screening
customers to check that they are affiliated with legitimate scientific enterprises
and have no criminal histories or terrorist associations. To screen customers, gene
synthesis companies are accessing various government-compiled bad guy lists,
such as the United States Specially Designated Nationals, Denied Persons, and
Statutorily Debarred Parties lists and Germanys Handbook of Export Controls
list.
This screening activity mirrors a public-private partnership initiated after
the September 11, 2001, attacks, when the FBI reached out to manufacturers of
dual-use goods and services that could be diverted from legitimate purposes to
harm U.S. citizens and property. Neither the FBI nor the companies want to see
such products hijacked for terrorist or criminal purposes. Moreover, each partner
has something the other wants. Governments want to halt proliferation, and the
companies, which may be contacted by aspiring proliferators, have information
useful in that quest. Governments, which devote staggering resources to identify
terrorists, front companies, black marketeers, and organized criminals, among other
unscrupulous types, have databases that can help companies avert ill-advised sales.
Thus, mutual interests and needs forged common-sense partnerships wherein
corporations notify the FBI of suspicious sales requests so that questionable
customers could be screened against its databases. This quiet practice currently
involves hundreds of businesses, including chemical and Internet companies,
resellers of dual-use equipment, and agricultural goods and services firms. Annually,
the FBI receives thousands of notifications of suspicious activity that enable law
enforcement authorities to disrupt and prosecute terrorist and criminal activities.
This experience proves that voluntary data sharing can help thwart the acquisition
of dual-use goods for malicious purposes.
Policy issues
The main international barrier to the spread of germ weapons is the Biological
and Toxin Weapons Convention, which lacks verification measures to unmask state-
level bioweapons programs. Impediments to the misuse of synthetic biology by
nonstate actors are similarly wanting. The sentinels on alert for angry spouses,
disgruntled employees, and terrorists with biological mayhem in mind, namely,
local law enforcement officers, have no training to recognize the Nipah virus, for
example, much less to be able to spot someone trying to synthesize this killer.
Thinking about how to govern the life sciences and other fast-moving areas of
technology needs to be jump-started:
Governance is lagging behind the life sciences revolution, in part because
policy makers, challenged to follow technical developments in this arena,
are not well-suited to devise governance approaches. These circumstances
do not presage government as the incubator of new, effective life science
governance measures, nor are there favorable odds that the international
community can agree on control measures, which would be less effective
unless universally applied. Moreover, another traditional wellspring of
invention, the academic community, is unlikely to widely support new
life sciences controls, which are seen as conflicting with academic
freedoms.
Whether the perpetrator is a state, group, or lone-wolf actor, todays
advanced technologies could facilitate acts that cause horrific death tolls
and massive economic and societal disruptions. A seventh pillar of
corporate responsibility is needed: industry best practices to prevent the
diversion of products for malevolent purposes.
In the end, industry may be the best engine for fresh, effective self-
regulation and, when needed, carefully balanced regulation in the life
sciences. Private sector scientists, savvy in both the technological
developments and business trends, are well positioned to identify choke
points, tactics, and avenues to prevent misuse of the life sciences.
Governments should incentivize life sciences companies to participate in
the governance discussion.
Only the exigent circumstances of September 11, 2001, gave rise to the
voluntary data sharing program, which the FBI has not exported. This
type of public-private nonproliferation partnership is more broadly
applicable to other sensitive technologies, equipment, and materials. For

starters, the U.S. government should lobby nations that are major suppliers
of advanced technologies to adopt this model.
on Science for Global Policy (ISGP) December 47, 2012, at the Hilton El Conquistador,
Tucson, Arizona.
Debate Summary
not-for-attribution debate of the policy position paper prepared by Dr. Amy
Smithson (see above). Dr. Smithson initiated the debate with a 5-minute
statement of her views and then actively engaged the conference participants,
responses made by Dr. Smithson. Given the not-for-attribution format of the
views of Dr. Smithson, as evidenced by her policy position paper. Rather, it is,
Debate conclusions
As a potential dual-use technology, governmental, private sector, and public
attention increasingly focuses on synthetic biology as a field requiring significant
oversight and/or regulation designed to prevent nefarious use and to monitor do-
it-yourself practitioners.
Public-private partnerships involving governmental entities and industry
stakeholders need to focus on voluntary self-regulation (e.g., screening
orders and customers) to mitigate concerns over the dual-use potential
of the rapidly evolving activities associated with synthetic biology.
Alternative approaches using regulation to block nefarious applications
and/or unwanted public uses must also be considered even though they
can be cumbersome and time consuming to implement and potentially
have significant negative consequences on financial investments and
innovation.
Ongoing discussions concerning oversight and regulations of specific

aspects of the synthetic biology industry are limited by the dearth of
experts with the specialized knowledge and the networks of worldwide
connections required to make effective decisions that do not impede
innovation.
Current realities
Although some legally binding regulations exist, synthetic biology is still an
emerging element of the life sciences, and largely unregulated. In this environment,
more flexible best practices and standards could be implemented on a voluntary
basis for self-regulation. The debate centered on the merits of a public-private
partnership in which industry stakeholders cooperate with international
governmental organizations to screen customers and their orders to prevent the
malicious use of synthetic biology.
There was consensus that imagination and flexibility are required to identify
the right questions concerning what can be realistically expected for the proper
and nefarious uses of synthetic biology. The September 11, 2001, attacks on the
United States were used several times as an example to illustrate the failure of
imagination on the part of policy makers regarding the potentially dangerous uses
of technology. The same mistakes need to be avoided when evaluating the benefits
and risks associated with synthetic biology. The conclusions concerning how to
balance productive innovation with potential dangers need to come from
discussions involving the private sector, government, and the public.
Concerns about synthetic biology were considered to be analogous to those
expressed about nuclear, chemical, and biological warfare that led to the
establishment of two public-private partnerships: the Financial Action Task Force
and the United Nations Security Council Resolution 1540 Committee. Similar to
these cases, it was suggested that global databases on synthetic biology already
established through the Federal Bureau of Investigations (FBI) voluntary data
sharing program, the International Association for Synthetic Biology, and the
International Gene Synthesis Consortium be expanded.
Private sector stakeholders are actively employing voluntary self-regulation.
Since many of their products are susceptible to being hijacked for malicious
purposes, these companies are subject to significant economic losses either directly
or through injury to their public images. Business-related concerns extend to
products made using synthetic biology that once released to the public, either
accidentally or purposefully, become part of the environment. In many cases, the
private sector considers self-imposed regulation (e.g., screening customers and

orders) to be preferable to new governmental regulations.
Some governments (e.g., the United States and Australia) were seen as
establishing sound oversight policies (e.g., certification processes, compiling quality
databases, and establishing liability protections both for businesses and consumers).
Questions were raised about how to properly monitor smaller, DIY-type
practitioners involved in synthetic biology. While no generally agreeable solutions
were proposed, it was emphasized that communication between the private sector
and governments concerning how to share screening databases designed to
comprehensively identify nefarious users was essential.
Another major concern was the availability of technology used by the DIY
community and those working in garage establishments that might be used in
an unsafe manner or for nefarious purposes. Questions were also posed concerning
the availability of new, cutting-edge equipment (e.g., desktop machines that allow
users to print DNA) as well as older unused and surplus machines that the private
sector and/or universities might sell at relatively affordable prices. There was debate
about how to ensure that the historical use of such equipment be organized to
avoid inappropriate uses (e.g., matchmaking old equipment for proper use in
less-wealthy countries). The U.N. Resolution1540 Committee has an element of
such matchmaking in its charter, but it could be expanded or offered through
another organization.
Synthetic biology has the potential to improve human access to the most
fundamentally important elements of life such as clean air, food, and water. It was
acknowledged that less-wealthy countries have a vested interest in pursuing
synthetic biology to develop everything from hardier crops to immunization for
their citizens. Through such applications, synthetic biology could help less-wealthy
countries transition from poverty to wealth. While a reasonable argument can be
made for countries such as Iran and Iraq to own dual-use technologies for peaceful
purposes (e.g., modifying foods or vaccine production), as a dual-use technology
synthetic biology poses a potential threat to regional and global peace via its
potential use to develop chemical and/or biological weapons. Voluntary data
sharing programs, governmental and private sector oversight of products and users,
and registration of dual-use equipment are all essential components of a
comprehensive system designed to ensure the peaceful use of synthetic biology.
Discussions about a self-regulation system for synthetic biology have already
begun with several private sector leaders worldwide. While private sector leaders
have been receptive to the idea of self-regulation, there are currently few regulatory
experts working in this area. Discussions among private sector stakeholders, public
interest watchdog organizations, and governmental policy makers are also under
way on a small scale, but it was deemed important to bring such discussions to a
higher, more inclusive global level.

The applications of synthetic biology span genetically modified organisms used in
foods to chemicals used for medicine to products of potential use in warfare. This
broad spectrum of applications means that synthetic biology and its methodologies
will be used in ways that are difficult to anticipate. These differences may materialize
as more- and less-affluent countries determine how synthetic biology may best
benefit their respective societies. Based on these potentially different approaches
(e.g., higher crop production and improving public health beyond the poverty
level versus enhancing corporate profits by reducing costs or developing more
efficient energy sources), extensive discussions centered on ensuring that synthetic
biology methodologies were made available to both more- and less-affluent
countries while maintaining effective systems for public safety.
There was general agreement that while anything from gasoline to bricks
could be used for good or bad, there exists a point where the potential for the
malicious uses of a technology requires governmental intervention, including
regulations designed to limit its use. It was agreed that many aspects of synthetic
biology rise to this level. It was noted that while there are such protocols already
available (e.g., the Australia Group list for controlling exports of potential chemical
and biological weapons material), prioritized guidelines are needed that consider
materials associated with synthetic biology that have the potential to be proliferated
quickly and affect large populations.
It was suggested that it would be useful to utilize gaming methods focused
on gathering groups of experts and policy makers to brainstorm unintended
consequences of synthetic biology or how they would try to circumvent existing
laws and regulations. This type of brainstorming is important because if an
organism produced by synthetic biology is released into the environment, either
unintentionally or with malfeasance, that organism may not be able to be recovered
or eradicated and may become a permanent part of the ecosystem.
Much of the debate centered on the hypothesis that a large opportunity for
public-private partnerships exists in which governments share a database of bad
actors with the private sector, which uses the information for voluntary self-
regulation. Described as win-win, such programs are already in practice with
some companies, and it was considered more expedient and effective than spending
years debating policies and legislation. Governments such as the United States
already have detailed databases of potentially unsafe practitioners. These databases

could be improved and aspects shared with the private sector by combining or
integrating information produced by individual agencies (e.g., FBI, Central
Intelligence Agency, and Drug Enforcement Administration). In addition, these
agencies have computerized systems using triggers/thresholds to identify a potential
buyer who needs to be scrutinized (e.g., purchasing too many ingredients or
technologies that, when combined, might result in illegal substances). Such
surveillance can prevent sales to potentially dangerous individuals or groups. It
was also suggested more funding must be made available to individuals who have
credentials and good connections in the private sector to allow them to seek out
voluntary partnerships for self-regulation and to identify more stakeholders in the
synthetic biology arena.
While it was suggested that synthetic biology practitioners be screened and
undergo background checks using current models for nuclear experts and workers,
dissenters argued that regulations in academia are already restrictive and that adding
such hurdles could reduce innovation. There was no consensus regarding imposing
these types of screenings for researchers in the private sector and academia, but it
was generally agreed that there must be some level of self-regulation. There is
incentive to self-regulate because of potential negative outcomes for companies
and institutions, such as bad publicity and financial liability resulting from misuse
of their products or research.
Bringing the public and nonexpert policy makers into the discussion is an
important part of the process, but it was acknowledged that both groups are often
not well informed about the current status of the science and technology. It was
suggested that to better educate the public and policy makers, media boot camps
and science media centers could be established to allow journalists to report more
easily and accurately on science stories.
Policy Issues
Governments are already aware that the life sciences, including synthetic biology,
must be monitored for dual-use concerns. In addition to the private sectors
preference for avoiding new regulations, it was also widely agreed that government
processes are extremely slow, and entangled in complex bureaucracy. Knowing
that new government regulations are under development, the private sector will
often wait until the last possible minute to comply. Voluntary agreements can be
put into place much more expediently than regulations, (e.g., it took 24 years for
the Chemical Weapons Convention to be ratified).
While government and academia may not be well positioned to innovate

governance strategies for the life sciences, including synthetic biology, the major
focus of the debate centered on the reality of high-level, global, voluntary self-
regulation on the part of private sector stakeholders. Talks with members of private
sector have already begun at an unofficial level, and they have been receptive to
this model. By compiling and sharing comprehensive databases of buyers and
orders, some of which already exist with separate government agencies, self-
regulation could be an effective component of synthetic biology governance.
However, more individuals with credible connections, knowledge, and funding
are needed to promote the idea of voluntary data sharing and self-regulation.
It was suggested that academia assume more responsibility in defining the
appropriate level of governance for synthetic biology. Unlike the nuclear arena
where researchers are expected to participate, be held professionally and criminally
accountable for their actions, and interact with and educate the public, life scientists
have been uninvolved with many aspects of regulation.
For many in the public, synthetic biology remains a mystery. Participating
in helping to educate the public needs to be mandatory for practitioners to
encourage the use of best practices, and to improve the acceptance of synthetic
biology in both the general public and among influential policy makers.
Regarding DIY practitioners in synthetic biology, it was noted that both
cutting-edge technologies such as desktop DNA printers and older, unused
machinery are becoming available on the open market. Industry must have an
incentive (i.e., minimizing financial liability) to restrict the sale of cutting-edge
technologies to unknown entities. Perhaps a matchmaking organization could
provide a way for older machines and instruments to be used safely. There also
needs to be an incentive for recycling or destroying those machines and instruments
that have the potential for nefarious uses of synthetic biology.
Realistically it is impossible to have all synthetic biology practitioners
voluntarily use best practices, but it is equally unrealistic to effectively police the
field through government regulation alone. Voluntary self-regulation using
government databases could be an effective compromise because of the speed of
implementation, incentive for private industry to participate, and the ability to
continually update databases for future use.
The Challenges of Deploying Synthetic Biology

Technologies in Developing Countries**
Maria Mercedes Roca, Ph.D.
Associate Professor of Biotechnology, Zamorano University, Honduras
Summary
The planet faces a perfect storm, caused in large part by a growing population
and environmental degradation. This will require producing more biomass for
food, feed, bioenergy, fabric, and materials with less land, water, and oil, and in the
face of climate change and rapid loss of biodiversity. Maintaining the status quo,
especially in developing countries, is not an option; we must act now. These
formidable challenges are also incredible opportunities for change. Humanity is
embarking on a new powerful genomic revolution, coupled with the digital and
nanotechnology revolutions. The field of synthetic biology (SB) offers the promise
of revolutionary new products to enhance health and create wealth. Like
biotechnology, SB will likely be regulated under the guidelines of the Cartagena
Protocol on Biosafety to the Convention of Biological Diversity (CP) for signatory
countries.
Policy makers must acknowledge both the potential of SB and the publics
deep mistrust of new, untested technologies they feel are outside their control.
The future success of SB depends to a large extent on whether public policy is well-
crafted. To build public confidence in the governance of SB, transparency, together
with adherence to high safety and environmental standards and ethical principles,
is essential. However, the all-important safety aspects of policy must be guided by
scientifically defensible, risk-based approaches rather than public opinion, especially
when the latter is driven by activist groups and political agendas. To promote
sustainable development and global harmony, industrialized countries also have a
moral imperative not to influence policies that limit development of other less
advanced countries and to learn from the missteps of regulating genetic engineering
that illustrate that choosing a flawed paradigm has critical implications for a
technology.
Current realities
In 2009, Sir John Beddington, United Kingdom Chief Scientific Adviser, warned
that the world of the 21st century faces a perfect storm of problems that include
food shortages, scarce water, environmental degradation, and insufficient energy
resources. These challenges threaten to unleash public unrest, cross-border
conflicts, and mass migration as people flee from the worst-affected regions. Rising
standards of living in developing countries will trigger a surge in demand for food,
water, and energy over the next two decades, at a time when governments must
also make major progress in combating climate change. These formidable problems
are all intimately connected. In the same way countries and regions are
interconnected, the actions, decisions, and policies applied in one region can have
profound social, economic, and environmental impacts in other regions. An
example of this is the excessive oversight of agricultural biotechnology, especially
in the European Union. This oversight has deeply influenced and could be
potentially devastating to agricultural development and food production in the
poorest nations of the world.
The formidable challenges need to be addressed with approaches that include
adhering to ethical behavior and deploying new technologies. The field of SB offers
the promise of revolutionary new products that could greatly benefit society, both
in industrialized and developing countries, by enhancing health, contributing to
care for the environment, and creating wealth. Building public confidence in the
governance of SB by following ethical principles and high standards of safety for
human health and the environment is critical. A key ethical principle is the sharing
of benefits from those technologies beyond the industrialized nations that are
pioneering the technology.
Many argue that care is needed to involve the public in discussions and
decisions relating to the development and use of new technologies (Sunstein, 2002)
especially those who invoke a strong version of the precautionary principle in
regulating new technologies like biotechnology, nanotechnology, and SB. Building
confidence in the governance of SB is necessary in assuring the acceptability of the
products of SB, along with ensuring that SB products meet the necessary safety
requirements and environmental standards. However, policy makers should also
learn from the example of genetic engineering, which illustrates that choosing a
flawed paradigm and democratic decision-making that involves many segments
of civil society who may not fully understand the complexities of the technology
can also have critical implications for successfully deploying that technology.
Sometimes, especially in developing countries, the general public, with a low level
of education, may not fully appreciate the technical complexities related to the
oversight of new technologies and the complex dimensions of risk science that
must form the basis of decision-making.

Great challenges offer great opportunities for change. Technologies as powerful as
those offered by nanotechnology, the digital revolution, and the genomics revolution
can significantly contribute to solving global problems. The risks posed by these
technologies must be carefully weighed against the benefits and the risk of inaction
and maintaining the status quo. This especially applies to developing countries
with the greatest increases in population, which arguably have the greatest
challenges. It may least apply to industrialized regions where population is
shrinking, food is plentiful, and health care and sanitation are adequate. There,
the main concern is not poverty, but continued economic growth and
environmental conservation. Environmental activist groups and self-styled
intellectual elites who purport to represent the public interest have negatively
influenced the adoption of agricultural biotechnology and demonized genetically
modified organisms (e.g., pest-resistant crops or sterile mosquito vectors to manage
diseases in developing countries). Many of these groups originate in regions, such
as the E.U., with challenges other than food security and widespread tropical diseases
(e.g., dengue).
SB is a logical extension of genetic engineering and will probably be regulated,
for signatory countries, under the auspices of the CP. Countries that have signed
and ratified the CP include the E.U. and most developing countries in the world,
although not the United States. The debate around the oversight of SB has been
initiated by NGOs active in the CP debate. These NGOs have asked the member
countries to adopt a de facto moratorium on synthetic biology, and to apply the
precautionary approach to field releases of synthetic life into the environment,
acknowledging states parties rights to suspend such releases.
Policy issues
Given the global challenges that need to be urgently addressed, regulation and
oversight should avoid unjustifiably inhibiting innovation, stigmatizing new
technologies, or creating trade barriers. As with the oversight of modern
biotechnology/genetic engineering, a case-by-case approach is necessary for SB.
We must not assume that all products or organisms derived from SB will be safe or
that all will be dangerous, and the U.S. approach of regulating the product and not
the process seems sensible. An identification of key categories of risk that includes
intellectual property (IP), biosecurity, biosafety, and ethics, and a categorization

of SB products and applications as proposed by Kuzma & Tanji (2010) offers an
obvious first step to develop appropriate international regulation. Further
recommendations include:
To adhere to ethical principles of benefit sharing and to contribute to
solving global problems under the principle of shared but differentiated
responsibilities (Rio +20), and to develop guidance frameworks that take
into account global interests, not only domestic.
What is an acceptable risk in a developing country will be different in a
developed country, particularly given the scale of the challenges faced in
the former. As such, the risk of testing new, unproven technologies versus
the risk of maintaining the status quo must be considered.
Take into account lessons learned from the oversight of other technologies,
such as agricultural biotechnology, and use informed risk assessment for
decision-making and not solely public opinion and political agendas.
Most of the training for the regulation of agricultural biotechnology has
been undertaken by UN agencies and NGOs involved in environmental,
and not agricultural, activities, which has distorted and slowed the rate
of adoption of this technology. National governments and the scientific
community, especially those in developing countries, should pay close
attention to capacity-building in risk science and biosafety regulation by
experts in relevant areas.
Carefully consider the balance of democratizing decision-making by
involving the public in an effort to build confidence in the governance of
SB and assuring acceptability of products versus adding great complexity
and different agendas to the decision-making process that could result in
inaction. Different regions have different agendas for public involvement
(e.g., environmental conservation in Europe and California versus access
to clean water in Central America). Discussions of certain issues should
involve wider society, but in developing countries, highly technical issues,
such as the regulation of genetically modified or SB products, are beyond
the general understanding of the public, who will not see past the
demonizing publicity of activist groups. Unfortunately, regulators in
developing countries will carefully watch what regulators in more-
advanced countries decide, especially when they dont understand a
technology, such as genetic modification.
Expand the capacity for the global scientific community to solve global
problems by having open access to information, without excessive
restrictions from intellectual property issues or excessive and costly
regulation.
Heavily regulating a technology to limit bioterrorism also limits its
potential to contribute to solutions. The excessive regulation and thus
high cost of agricultural biotechnology has resulted in the almost exclusive
dominance of this technology by big industry and the exclusion of public-
sector institutions (universities) and small companies. This fact should
outweigh the threat of bioterrorism and should influence the regulation
of SB.
Allow the initial technical or biosafety problems from the first-generation
products of SB to be solved by approaches developed in second-generation
products, without unjustifiably inhibiting innovation by excessive
oversight.
References
Sunstein, C.R. (2002). The paralyzing principle. Regulation. 25(4), 32-37. The Cato
Institute.
Kuzma, J. & Tanji, T. (2010). Unpacking synthetic biology: Identification of oversight
policy problems and options. Regulation & Governance. 4, 92-112.
Tucson, Arizona.
Debate Summary
not-for-attribution debate of the policy position paper prepared by Dr. Maria
Mercedes Roca (see above). Dr. Roca initiated the debate with a 5-minute
responses made by Dr. Roca. Given the not-for-attribution format of the debate,
the views comprising this summary do not necessarily represent the views of
Dr. Roca, as evidenced by his policy position paper. Rather, it is, and should be
read as, an overview of the areas of agreement and disagreement that emerged
from all those participating in the critical debate.
Debate conclusions
While regulation may be necessary to control synthetic biology and other
emerging technologies, it can stifle innovation to the detriment of society,
particularly in less-affluent countries.
Given that risk-benefit framework is useful when evaluating a new
technology and may also be applied to regulation as well, the risk-benefit
equation will vary widely as it is applied to various countries and cultures.
Consequently, there can never be a one-size-fits-all solution to
regulation.
Synthetic biology has engendered widespread support and excitement,
especially among young scientists, and is advancing at a faster rate than is
generally seen with emerging technologies.
The democratization of decision-making is a necessary tool for engaging
all stakeholders, in the effort to build a consensus around effective policy
decisions and educating the public to ensure broad-based support.
Current realities
Although synthetic biology is generally thought of as a transformative technology,
both exciting and frightening in its potential, there is also an aspect of routine or
ordinariness in the application of synthetic biology. It was noted that one of the
initial manifestations of synthetic biology will likely be in the area of vaccine
production. While synthetic biology will be used to create a synthetic virus, that
can be grown on a production scale, it will then need to be killed to be used to
produce a vaccine. There was general agreement that the regulatory process to
approve the distribution of that vaccine would largely be unchanged from that
used currently. There will be only a few modifications to the approval procedure
since the end product vaccine will be similar, if not identical, to vaccine products
manufactured by traditional means. From the point of view of the consumer, the
vaccine is essentially the same as prior versions, having just been produced more
efficiently. Consumers negative views concerning new technologies that are used
to produce vaccines (e.g., synthetic biology), may result in their reticence to use,
or even outright reject, such products.
The promise and excitement of synthetic biology as a new technology, driven

by young people who have formed their own communities, was highlighted as one
of the most important aspects of this emerging field. It was proposed that this
aspect of the technology will be a primary driver in its adoption and dissemination
and that the excitement factor should be used when discussing synthetic biology
with policy makers and the general public. It was suggested that synthetic biology
almost has a life of its own, and that over-regulation could stifle progress in the
advancement of the technology.
Although the concept of a risk-benefit evaluation for a new technology (or
technology product) is well-understood, there was general agreement that the
application of such an evaluation process will result in a different conclusion for a
less-affluent country than for a more-affluent country. As an example, the benefits
from genetically modified mosquitoes were recognized as a potentially life-saving
advancement in several less-affluent countries, but regulators in more-affluent
countries may have difficulty understanding the importance of such a mosquito.
Safety standards were considered an important part of the risk-benefit equation,
and must not be relaxed. Rather, pragmatism and economic reality may result in
different applications of safety standards, especially in less-affluent countries. The
example cited was the development of a genetically modified banana, resistant to
black sigatoka disease, which was halted due to anticipation of rejection by European
markets/regulators.
There is a historical context of public and scientific reactions to various
technologies. In the late 1980s, with agricultural research funded by the
international community, food distribution was the major concern in certain low-
income countries. However, in the early 1990s, there was a shift in international
development and research from agricultural issues to issues surrounding the
environment, particularly in regards to climate change. The decline in agricultural
funding was quite pronounced, shrinking by 67% over two decades, resulting in
the elimination of basic agricultural services (e.g., extension services) in some less-
affluent countries. In the last five years, these conditions have resulted in higher
food prices and supply shortages, and agricultural issues are now beginning to
once again gain the attention of the international development community.
Major policy issues tend to have long lives, but the public perception
surrounding these issues tends to vary over time, swinging like a pendulum. The
analogy of womens rights was presented, comparing a previous generation that
fought for womens rights in the face of a very traditionalist environment with the
next generation, in which the pendulum swung back. Presently, this issue is near
equilibrium, with a healthy mix of personal and professional lives and priorities.
This analogy was then compared to environmental activism, which was also once
quite strident, but may be approaching a balance between environmental protection
and scientific progress.

The notion of synthetic biology being isolated and identified as an autonomous
and unique element of biotechnology and biology was debated. Treating synthetic
biology as a separate and distinct technology, as opposed to just another advance
in biotechnology, may result in heightened scrutiny by regulators and by activists
who generally oppose emerging technologies.
Involvement of a variety of stakeholders in discussions and decisions around
synthetic biology and also in scientifically complex issues was considered important.
This democratization of decision-making is a consequence of the instantaneous
and pervasive dissemination of information, primarily through the Internet.
However, it was also argued that involvement of nonscientific and, in some cases,
community stakeholders with lower levels of education, actually resulted in such
stakeholders deferring to experts, or expressing opinions without a complete
understanding of the issues at hand. Democratization of decision-making was
recognized as a benefit and a necessity, but it was also described as a double-edged
sword that increased the complexity of decision-making.
Limiting development of synthetic biology and other such emerging
technologies in high-income countries may lead to unintended consequences. The
first of these may be that the lack of advancement of such technologies in more-
affluent countries may prevent countries with fewer resources from being able to
advance and utilize these new technologies on their own. A second unintended
consequence is the possibility that multinational organizations/corporations may
seek out countries with less robust regulatory environments in which to conduct
research into these new technologies. Another related aspect of regulation of new
technologies is the extent to which a body of regulation may act as a barrier to
entry or advancement of said technology by certain stakeholders. This mountain
of regulation may prevent university researchers from pursuing synthetic biology
and other advances, as it is too expensive for them to even consider. Small start-up
companies were also noted as potential casualties of what may be perceived as
excessive regulation.
Animal cloning was discussed as an example of a technology with differing
regulatory and risk assessment stances in various countries. Several years ago, a
cloning risk assessment group was convened in the United States to consider the
safety of consumption of food from cloned animals, and concluded that such food
was safe to eat because it was produced through traditional sexual reproduction.
However, when a similar group of scientists was convened and came to a similar
conclusion in Europe, the risk assessment was sent back by the European
Commission five times for re-evaluation, and still has not been resolved in Europe.
The need to educate on a variety of levels was debated. A science curriculum
for children and a program focused on biotechnology for secondary education
were noted as essential, as well as the need to educate and provide resources for
science teachers. Several countries, such as Cuba, Venezuela, Brazil, Argentina,
and Colombia, were noted to have significant programs to engage young people in
science. The education and engagement of policy makers in scientifically complex
issues was also introduced. While scientists may not always be the most effective
communicators to the lay public, it was proposed that scientists continue to develop
and utilize communication and advocacy skills.
While reducing the degree of regulation may raise concerns about exploitation
of the public, if scientists were prohibited from pursuing certain areas of research
in their home country, they may attempt to move to regions that are welcoming to
outside scientists. In this scenario, it is possible that, even with good intentions,
scientists may implement protocols that are perceived as exploitative of their
research subjects and/or the community in which they are working. The possibility
of this happening is particularly strong when scientists are working outside of their
own cultural framework.
Policy issues
Aspects of global harmonization of regulations and policies relating to biologics
and emerging technologies were discussed. While it was agreed that general
multinational guidance in these areas provided a useful framework, it was important
to allow and encourage specific policies and regulation at the country level, to
allow and encourage autonomy, as well as interweaving demographic, cultural,
socioeconomic, and political beliefs into the regulatory fabric.
The need to get political leaders to understand the risks involved in these
technologies as well as the costs of inaction was raised in the context of the ease
with which special interest groups can exploit such an issue. This political reality
was considered a significant and pervasive problem. While not directly addressing
this problem, it was suggested that more-affluent countries could focus on
demonstration projects in less-affluent countries as a way to show progress and to
gain comfort with new technologies.
While there was consideration of a de facto moratorium of synthetic biology,
the precautionary principle leads logically to a research agenda that could serve
the public interest and is not driven by individual organizations. Alternative

approaches to synthetic biology applications have been considered. As an example,
a genetically modified mosquito is being researched to alleviate or eradicate Dengue
Fever, and a vaccine for Dengue Fever also is being developed. It was proposed
that one way of evaluating these alternative approaches would be to compare both
by conducting full and inclusive assessments of the implications of this technology,
including a comprehensive means of assessing human health effects, environmental
and sociological impacts of synthetic biology, and preventing negative outcomes.
The possibility that regulations applied by a high-income country have
actually hindered research in a low-income country was raised. For example, a
collaboration between U.S. and Honduran laboratories for a genetically modified
tomato had allowed the laboratory research work to be easily transported and
translated between countries. But the cost for the Hondurans to effectively address
and adhere to the regulatory framework was prohibitive. Certain countries (e.g.,
Brazil) with less onerous regulatory environments exist that are large enough to
fund and advance research on their own.
The Convention on Biological Diversity (CBD) was characterized by some
as simply an effort by the less-affluent world to level the playing field. Others
argued that CBD was primarily a vehicle to protect biological diversity in less-
affluent countries and to be able to derive the benefits that emerge from biological
diversity. However, due to three other unanticipated and uncontrollable realities,
the CBD may have less leverage and relevance than originally hoped. The first
reality noted was the strength and reach of multinational corporations. Second,
genetic engineering is even more robust than it was when CBD was first enacted.
Third, agricultural, food, and energy issues and problems are now impacting
forefront policy decisions. While this analysis was not disputed, it was argued that
it is difficult for any large multinational treaty to appropriately address the needs
of a diverse group of individual countries.
While research to develop a recombinant banana resistant to black sigatoka
was not pursued because this genetically modified fruit would not sell in Europe,
it was suggested that given the declining population in Europe, serious consideration
needs to be given to moving marketing focus away from Europe toward rapid-
growth countries that are more supportive of the benefits of emerging technologies.
It was further argued that people who are facing famine and food security issues in
less-affluent countries may soon apply direct political pressure on their leaders to
adopt synthetic biology and other emerging technologies that ameliorate these
challenges.
The Challenge to Meet Global Need for

Protein Sources for Animal Production**
Eliot M. Herman, Ph.D.
Professor, School of Plant Sciences, University of Arizona,
Tucson, Arizona, United States
Summary
Increasing prosperity in populous countries has accelerated animal production at
a much higher rate than the growth in human population. The current annual
global feed need is 1 billion tons and there is an emerging crisis for increases in
high-quality protein feed sources to support animal production. Today, animal
production is reliant on soybeans, which form the bulk of world commerce of feed
protein. Current trends and needs show that soybean and alternative protein crops
will be needed to keep pace with demands for global livestock feed. Biotechnology
using new synthetic biology methods can provide the means to enhance soybean
production and develop new feed sources by reconfiguring other crops as protein
production platforms comparable to soybeans.
Current realities
Efficient animal production requires feed with high protein content. While maize
(875 million tons produced in 2011) provides much of the carbohydrate source
enabling animal production, other crops provide much of the protein. Current
global feed protein supplies are dominated by soybeans, canola meal, animal by-
products, fishmeal, as well as many other less abundant and regional sources. Only
soybeans, canola, and fishmeal are truly products of global commerce, where the
feed protein sources from one part of the globe are used to support animal
production in other parts of the world, and often with delivery of the animal
products to yet another part of the globe. As more populous nations become
prosperous, there is and will be greater pressure to increase animal production.
The impact this will have on land and water resources, competition between food,
feed, and fuel, and the need to escalate feed and animal production is a global
concern. Global animal production is growing much faster than the rate of human
population growth.
For the foreseeable future, soybeans will remain the single greatest protein
source to support animal production. The meal from 85% of the 251 million tons
of soybeans produced globally (2011) is used to produce animal feed. Soybeans
produced in the Americas are a global commerce product and form the basis for
expanding livestock production in Asia, a region where growth in animal production
has been most rapid. Canola meal, a byproduct of seed oil production, is another
major source of vegetable protein, although it constitutes only a fraction of the
soybean commerce. Although only 2%3% percent of global protein commerce,
fishmeal remains an important contributor to protein sources for animal
production. In fact, 25% of all fish caught are processed to make fishmeal. The
use of fishmeal leads to human health issues by concentrating mercury and PCB
pollutants that has attracted the attention of government regulators, who have
issued warnings against consumption of fishmeal-fed aquaculture products. The
use of fishmeal also has a negative impact on the marine environment by removing
the forage fish base of the food chain. Terrestrial animal byproducts remain a
significant reprocessing source of feed protein (4%6%), although in the aftermath
of the Mad Cow episode in Europe their use has been greatly diminished by
regulation and by consumer choice.
There has been limited use of synthetic or transgenic biology to improve the
content and quality of plant protein products used for animal feed; more effort has
been directed at improving the protein quality for crops directly consumed by
humans. However, the development of these products has been stymied by anti-
GMO politics. The Gates Foundation has funded biotechnology projects directed
at improving protein content and quality in staple crops, especially in Africa. Other
international programs have used conventional breeding to create rice and maize
with enhanced essential amino acid balance, and there have been similar breeding
efforts to enhance the major feed protein crops (soybeans and canola), with limited
impact.

The improvement of current feed crops through biotechnology is critically needed
to enhance their production and quality. As the major global supply of feed protein,
the soybeans critical role in the feed industry has made its long-term enhancement
a strategic objective. However, because soybeans only grow productively in certain
regions of the world, additional sources of plant protein are needed, especially if
the crops can be grown productively and economically in global regions where
soybeans are not produced. Such crops might be targeted for the cooler northern
regions currently dominated by cereal production and/or be able to tolerate the

arid and more saline regions of the globe.
The use of synthetic biology to enhance crops is still in its infancy. Almost all
of the current transgenic crops exhibit traits designed to limit the impact of insects,
viruses, or competitive weeds, which primarily benefit producers. Only recently
have consumer-valued traits begun to emerge, such as low trans-fat soybean oil
conferring a health benefit as a source of fry oil. Engineering a plants protein quality
and quantity to date has largely been in the context of attempting to improve protein
content and quality in the starchy staple crops used as human food in less-developed
nations. Biotechnology may be able to create a new soybean from other crops.
By using genomics as the basis to alter the genetic program of other crops, it is
feasible to use synthetic biology to engineer other crops to possess protein qualities
similar to soybeans. One example is our project at the University of Arizona where
we have altered Camelina, an oil seed crop related to canola, to have output traits
very similar to soybean plants. This plant grows in northern climates, tolerates
arid and marginal conditions, and can be grown as a winter crop between soybean
crops, enhancing the productivity of existing farmland. We are developing this as
a potential feed source engineered by synthetic biology because, from an agronomic
perspective, it can be grown in competition with maize and soybeans, including
on marginal land. Camelinas other favorable characteristics are that it is not used
as human food, thereby avoiding issues of transgenics in food, and being European
in origin, there are no native plants capable of genetic out-crossing with Camelina.
Current Camelina production is directed at biofuels with a meal side-product, a
situation we envision to reverse, with the meal being the primary product for feed
and the oil as a byproduct.
Policy issues
International centers for feed research and development. The increasing
need for protein sources for livestock feed is a global concern and should
be supported through education and research investments by
transnational projects. There are ample opportunities for NGOs as well
as governments to use livestock feed for bilateral and multinational
projects. There are many international organizations involved in crop
improvement, but none of them are specifically directed at animal feed.
The Food and Agriculture Organization (FAO), the Pew Trusts, and other
organizations have published white papers on the needs and the looming
crisis in animal production, but these have not specifically called for
establishing one or more international centers encompassing terrestrial

and aquatic animal species. Such centers would, of necessity, need to
bridge crop improvement and animal health and production. Animal
feed research centers will need funding streams that require government,
industry, and foundation support.
Enhance the productivity and composition of current feed crops. For
example, as a global commodity, fractional increases in soybean
production could have immense impact. Because soybean trait
enhancements will likely be transgenic through synthetic biology, there
are persistent regulatory impediments.
Develop new feed crops. There are many potential plants that could be
developed into enhanced feed using synthetic biology. The Camelina
research under way at the University of Arizona is but one possible
example. The U.S. Department of Agriculture currently funds
development of new crops with intramural and extramural programs
primarily aimed at human food and biofuels. This program could be
expanded to include animal feed crops and serve as an example for the
funding agencies in other nations.
Address the competition between biofuels and feed. The use of food
crops for fuel is increasingly controversial, exchanging global food supplies
for fuel predominantly for industrialized nations. There is a growing world
opinion that using food as fuel increases food costs and decreases supply.
Moving to next-generation biofuels or nonbiological alternatives will
increase global food supply. Transgenic synthetic biology will enable the
development of fuel crops or algae to be superior sources of fuel, releasing
the crops currently converted to ethanol and biodiesel oil. Current global
funding for next-generation biofuels should evolve quickly to support
the goal of transferring food/feed crops to their traditional use.
Increasing regional production of alternative vegetable feed. With
soybeans and maize as the current primary global feed sources, the center
of their production in the Americas is far distant to the growing sites of
animal production in Asia. Alternative feed sources from other continents
will improve sustainability and economic viability. Alternative feed
development should be a priority for international research centers funded
by government and/or NGO sources, needing only a small fraction of the
funding now expended on research on important human food crops.
Abolish the use of fishmeal for animal feed and replace it with
sustainable vegetable protein. Fishmeal provides only a small fraction
of global protein for animal production, but its use has a major impact
on world fisheries and ocean productivity. By using transgenic synthetic
biology approaches, it should be feasible to engineer sustainable vegetable
protein substitutes for the small fraction of global feed protein currently
supplied by fishmeal.
Tucson, Arizona.
Debate Summary
not-for-attribution debate of the policy position paper prepared by Prof. Eliot
Herman (see above). Prof. Herman initiated the debate with a 5-minute
responses made by Prof. Herman. Given the not-for-attribution format of the
views of Prof. Herman, as evidenced by his policy position paper. Rather, it is,
Debate conclusions
The potential of synthetic biology to create vegetable-based protein crops
with less water and fewer resources may significantly expand the food
and feed production in precisely those geographic regions where more
food and/or feed is needed.
The expensive and time-consuming regulatory and approval processes
now in place for genetically engineered plants must be streamlined if the
looming food and feed challenges are to be met.
The preliminary indications that plants engineered via synthetic biology

could be substituted for fishmeal (an animal feed known to negatively
impact ocean sustainability) strongly suggest that such research be
significantly expanded.
Although biotechnology may have the ability to address many parts of
the food crisis, sociopolitical factors, as well as geographical disparities in
the production and distribution of food among more- and less-affluent
countries, need to be considered in formulating and implementing
effective policies regulating biotechnology.
Current realities
The impending rapid rise in the human population will require increased animal
and animal feed production. While soybean crops are the main animal feed protein
source, current production does not constitute enough protein capacity to supply
future needs. Although soybeans are largely produced in the Americas, they are
exported to areas where the demand for food is surging (i.e., Asia). Finding
alternative plant protein sources, grown locally to reduce transportation expenses,
was viewed as a priority. Designs based on synthetic biology of new crops arising
from genetic modification of currently cultivated plants, or from other plants not
currently used in agriculture, was viewed as a potential solution to the impending
shortfall in the amount of crops available for animal feed.
Concern was expressed about the time constraints for gaining regulatory
approval for crops derived from biotechnology. While the time to develop a new
crop averages about 10 years, regulatory approval for a new crop averages about 13
years and costs nearly $135 million in the United States (compared with $10 million
in Brazil). Such constraints were seen as a dramatic limitation to the development
of new crops because it is unlikely that a company could afford such expenses
unless the predicted revenues exceede $1 billion. Given that the shortfall in animal
feed is rapidly increasing, regulatory approval was generally seen as a hindrance to
development of new crops needed to meet anticipated demands for food.

Potential solutions for how to achieve the required animal feed production increase
were discussed. The near-term shortage of protein-rich feed emerged as the most
urgent issue and synthetic modification of crops to achieve enhanced protein
content was considered a viable and economically sustainable solution. For example,
Camelina has been engineered from being oil-dominant to protein-dominant and
could be used as a soybean proxy in providing protein-rich animal feed. Camelina

has been further modified to grow during the winter season, thereby maximizing
land use during a previously dormant season. In contrast, other technologies such
as tissue culture-based meat (i.e., animal muscle tissue grown in vitro), although
valuable, were seen as still enormously expensive and not yet possible on a large
scale.
While it was argued that animal feed (e.g., soybean and maize) should be
produced in the regions of surging demand (i.e., Asia), it was also pointed out that
the harvest of these crops is restricted to the temperate regions of the planet and
limited to certain periods of the year. Although the U.S. has a huge amount of
land available, much of this is not being utilized during winter. In this respect,
engineered cold-tolerant Camelina was discussed as a specific genetic change that
could be utilized in other plants to help increase animal feed production in countries
with increasing demand for animal feed. It was also highlighted that the populations
of more-affluent countries are increasingly becoming obese, while those in less-
affluent countries are affected by malnutrition and hunger, raising the question of
whether the main issue is one of distribution. The debate was dominated by
contrasting positions, with some advocating the need for better allotment of
resources and others suggesting that enabling less-wealthy countries to use the
technology would allow them to ameliorate their own food shortages.
It was debated whether the solution to future food shortages should be
technical or sociopolitical. Given that technology innovations influence societal
interests and needs, it was argued that a distinction between technical and societal
problems should be avoided. In this respect, since some technological changes
could be seen as challenging certain social or cultural aspects of some societies,
identifying the problems that require technological solutions is a major political
challenge. The white missionaries approach, seen as the tendency of more-affluent
countries to dictate to less-affluent countries regarding how they should solve their
problems, was considered a deleterious approach. Therefore, the importance of
having both synthetic biologists and social scientists collaborating emerged as
crucial, with some countries making this a requirement for grant submissions.
Sociopolitical approaches to countering the animal feed shortfall, such as
community education toward a healthier diet (i.e., a lower calorie intake) in
commodities-rich areas, setting of export limits, and imposition of new taxes or
food rationing, are potential solutions for more equal distribution of resources. In
this respect, attention was called to the necessity of reaching a global agreement to
ensure that the remaining resources would be equally distributed worldwide.
Fostering international accords will be valuable, but this goal will be extremely
difficult to achieve because of the dominance of consumerism and overabundance

of food in the more-wealthy countries. For instance, it was seen as unlikely that
the U.S. or European countries would drastically reduce meat consumption to
achieve equal distribution around the planet.
In Asia, desire for a wider variety of food (quality) is rapidly growing versus
a fundamental need for basic food (quantity) in Africa. It was noted that feed
resources in Asia would need to be deployed for growing different animals, thus
ensuring the availability of different meats, while in the African focus needs to be
concentrated on providing enough food to people in the first place. The debate
largely centered on the importance of guaranteeing a balanced diet for everyone
(e.g., by encouraging the growth of protein-rich grains in Africa to supplement
the existing and predominant starchy staple crops).
Particularly debated was the topic of fishmeal as a protein source in animal
feed, in relation to its sustainability and possible alternatives. At present, the amount
of wild fish caught to feed farmed fish is between 20% and 40% of the total biomass
of fish in the ocean. Because of a rise in protein demand, the amount of fishmeal
required is projected to increase. While the presence of omega fatty acids makes
carnivorous fish a healthier food source, the use of fishmeal is environmentally
harmful because of the reduction of ocean biodiversity. Creating a plant that
contains the appropriate protein and fatty acid content was suggested as a potential
solution to overfishing. However, though modern technology may be capable of
engineering new plants as an alternative to fishmeal, no government has made this
a funding priority. Moreover, since the digestive tract of carnivorous fish is unable
to digest plants, it would be necessary to further genetically modify a plant fed to
such fish to make it more digestible.
The ecological sustainability of protein-enriched plants was strongly
questioned regarding the potential increase in soil depletion and unintended gene
flow. It was countered that the impact of nutrient-enriched plants on the land is
not different from that of conventional crops. The lesson learned from genetically
modified soybeans was that not only were the water consumption and soil depletion
the same as for the wild plant, but that there was no evidence of gene flow. However,
it was agreed that the impact of new genetically modified plants needs to be assessed
on a specific case basis and potential undesired gene flow (e.g., herbicide resistance
in Johnson grass) must be avoided.
Public research and academic institutes, as opposed to private research and
development departments, have encountered difficulties in the development of
new crops, due in part to unrealistic expectations from funding agencies when
compared with the relatively small amounts of grant money they provide. Given
the high costs worldwide of regulatory processes, there was general consensus that
public research laboratories with relatively low operating budgets would be unable
to advance their research to a market level. A solution to both speed and cost
issues was identified with the necessity of quickly moving beyond the existing rules
and concentrating on the nonregulated aspects of the proposed new product.
Policy issues
To ameliorate the upcoming shortfall in food supply, crop production, and food
distribution, it was suggested that governments should fund and encourage the
use of synthetic biology to engineer new plants with optimized nutrient ratios
and/or physiologies.
To address issues of unequal distribution and access to food resources, policies
need to be created to reduce food waste and educate people from more-affluent
countries to eat a healthier diet (including ingesting fewer calories). In addition, it
was proposed that technological knowledge should be spread more freely to less-
affluent countries so that they can produce the crops they need.
To preserve the environmental sustainability of the oceans, there was general
agreement that the use of fishmeal for animal feed needs to be abandoned and
substituted with a vegetable source of feed. Most of the agricultural industry has
already expressed willingness to limit the use of fishmeal, primarily because of
problems such as the concentration of PCBs and mercury in fish that have raised
safety concerns. While creating new institutions or international regimens for
the creation of bioengineered crops was proposed, it was argued that most of the
existing regulatory framework is already focused on these topics. For instance, the
U.S. Department of Agriculture (USDA) is already monitoring open field use of
genetically modified plants, while the Food and Drug Administration (FDA) reviews
the nutritional components of engineered crops.
Since nitrogen and phosphorus are the most important elements for growing
any type of plant, export of crops could be considered as the export of nitrogen
and phosphorus themselves. This view raised the issue of importing the same
nutrients back to nourish the land. The economics of crop export and nutrient
import must be carefully managed and the soil depletion rate closely watched.
While there are many examples of new scientific discoveries for which an
application has not yet been found, there are numerous needs for which basic
science is not investigating. In this context, there was disagreement regarding
whether the scientific advancements should develop after the policies have been
created, or if regulations should be imposed after the potential of a new technology
has been evaluated. It was proposed that regulations and policies be formulated
after problems with the technology have been raised and solutions developed,
although there was not consensus on this point.
An ongoing competition exists between biofuel feedstocks and food crops
for both land and plant uses. Biofuels are currently produced from food crops
(e.g., corn) despite the fact that 854 million people are undernourished and the
demand for food and animal feed supplies is projected to rapidly increase in the
next 40 years. Although new approaches may be contested by the agricultural,
environmental, and energy stakeholders, it was proposed that biofuels of the future
not be produced from food crops but rather alternative biofuel crops (e.g.,
switchgrass or algae) be created through bioengineering.
The lack of food supply in less-affluent countries was attributed to distribution
issues caused by more-affluent countries (e.g., unequal partitioning of supplies
and a failure to act responsibly to cut food waste). However, others rejected an
equal food distribution policy, suggesting less-affluent countries could solve their
problems within their own borders. That the U.S. Agency for International
Development (USAID) spends 85% of its budget with U.S. corporations while
only 15% is actually assigned to aiding less-affluent countries raised a discussion
on the need to re-think USAID spending. For instance, by shifting the USAID
budget toward more substantial grants, research groups from less-affluent countries
would have more resources to develop new crops. At the same time, by allocating
more funding to the development of less-affluent countries, capacity could be built
to engage foreign research institutions, educate local people, and utilize local
knowledge to develop new crops derived from plants that more-affluent countries
may not have considered.
There was agreement that it is critical to streamline and accelerate the
regulatory process. In particular, it was suggested that rather than constantly re-
evaluating aspects of biotechnology that have been examined in the past, regulatory
agencies focus only on new or novel components. Accelerating the approval process
was seen as crucial for engineering new plant types to address key societal challenges,
especially in lower-income countries.
Safeguarding the Genetic Firewall with Xenobiology**

Markus Schmidt, Ph.D.
Founder
Biofaction KG, Vienna, Austria
Summary
While progress is being made in synthetic biology to make biology easier to engineer,
the safety regulations and risk assessment practices will soon be rendered outdated
and inadequate to handle upcoming developments of synthetic biology functions,
organisms, and products. Xenobiology, the science of biological systems made out
of alternative biochemical structures, may provide a new set of tools to establish
an innovative solution, a genetic firewall, to future biosafety challenges. This genetic
firewall will provide a stronger safety framework than would a series of small ad
hoc fixes to a set of regulations designed for genetic engineering. Decisive and
collaborative action by scientists, policy makers, and other stakeholders is needed
to face the medium- to long-term biosafety risks of synthetic biology.
Current realities
The potential future release of deeply engineered or novel synthetic microorganisms
raises the issue of their intentional or accidental interaction with the environment.
Containment systems, risk assessment, and safety regulations designed for genetic
engineering in the 1980s and 90s, for the purpose of limiting the spread of
genetically engineered organisms and their recombinant traits, are still largely
viewed by regulators and scientists as sufficient for contemporary synthetic biology
products.
Progress in synthetic biology is expected to yield a staggering growth in the
number of new biological functions and modified organisms with useful purposes.
These developments will sooner or later pose a significant problem for established
biosafety and risk assessment practices. A technological development that is
outpacing its safety regulation is going to end up in (i) a series of unintended
consequences and unforeseen accidents, (ii) a legal bottleneck for further product
development because of a lack of a clear legal and regulatory framework, and/or
(iii) increasing, and well justified, public resistance toward synthetic organisms if
they are not considered to be safe enough. So far, no safety mechanism is available
to provide a sustainable solution to this dilemma. Past suggestions such as so-
called suicide circuits (that would kill the cell once it escapes into the environment)
have failed to provide a sufficient degree of safety for industrial, medical, or
environmental use. No strategy beyond the decades-old approach to biological
containment is currently envisaged, despite significant investments and first
successes in synthetic biology that have made biology easier to engineer.

Most synthetic biologists try to convert biology into an engineering discipline by
redesigning existing, natural biological systems for useful purposes. This means
that synthetic biologists are using genes found in nature or designing new ones
that closely resemble natural genes. Some bioengineers, however, are not satisfied
with the biochemical substrates found in nature and try to construct new forms of
life, called xenobiology, that have no counterpart in the extant world.
The synthesis of alternative biological structures focuses mostly on the three
universal molecules: DNA, RNA and proteins. Recent research shows, for example,
that all subunits of the DNA (base, deoxyribose, and phosphate group) can be
replaced by alternative chemical structures. A DNA with three instead of only two
base pairs has been made, and other carbon ring structures such as hexose or
cyclohexenyl were incorporated to give rise to HNA and CeNA respectively (for all
non-DNA, non-RNA molecules the term XNA is used, which stands for xeno nucleic
acids). It was even possible to incorporate non-natural amino acids into proteins,
so they are made up of 21 or 22 instead of 20 amino acid building blocks. First
attempts have been made to come up with a biochemistry that has the opposite
chirality of natural building blocks. So, instead of using left-handed proteins, future
mirror life forms might use right-handed proteins. These experiments have
mainly been carried out in vitro and very few if any (depending on the definition)
living organisms exist with an altered biochemistry. However, sooner or later we
will see the construction of new-to-nature or xenobiological systems that are
increasingly farther away from their natural counterparts.
Xenobiology provides three main opportunities
1. Better understanding of the origin of life. Looking at all the possible
alternatives to life as we know it, the different variants of XNA, the
hundreds of amino acids not used in proteins, the universal genetic code,
or the selection of one type of chirality, the questions are: Why was this
basic chemical make-up evolutionarily successful while others were not?
Were these chemistries more robust, more likely to emerge under the
conditions of early Earth or was it by chance? And, is there room for an

artificial biodiversity?
2. More efficient industrial biotechnology production systems. Although
Earth has experienced billions of years of evolutionary trial and error,
nature has (by far) not tested all possible biological systems. This means
that it is likely possible to find new and more efficient biological functions
than those provided by nature. This approach constitutes a promising
way to design a new class of chemically diversified biocatalysts for
industrial, medical, and environmental biotechnology. Industrial strains
with a fundamentally different genetic code would suddenly be immune
to natural phages or viruses.
3. A solution to the upcoming biosafety challenges. Xenobiological systems
could be used as a fundamentally new biosafety system. Since they are
not capable of horizontal gene transfer between the natural and new-to-
nature organisms, the separation from the extant biology acts like a
genetic firewall (see Figure 1).
While the first point addresses deep philosophical questions, the last two
points deal with real-world implications for society, economy, industry, policy, and
the environment. The use of xenobiology in industry, however, will primarily
depend on whether it will be safe to use. Therefore, it ultimately comes down to
xenobiology as a way to provide a genetic firewall to improve biosafety.
Constructing a xenobiological organism and a genetic firewall is a very difficult
task, and beyond the current capabilities of science and engineering. Not only is it
difficult, it might provide hardly any return of investment over the short-term
future, since the establishment of a xenobiological toolkit and expertise will take
some time before reaching a level that is remotely comparable to bioengineering
with traditional biochemistries. But over the mid- and long-term the investment
will pay off, both in terms of increased efficiency of biotechnological processes
and in terms of providing a safe and reliable mechanism that avoids unintended
consequences, accidents, and legal uncertainties.
Policy issues
Synthetic biology, extrapolated into the near future, will result in a radical increase
in the number of synthetic biological functions, organisms, and products. Policy
makers need to realize that these developments will render the current regulatory
safety framework (designed for genetic engineering) outdated in a not-so-distant
future.
The response to this development may either be (i) inert, ad hoc, tactical
adaptations of obsolete safety regulations and risk assessment without a
clear strategy, or (hopefully) (ii) a collaborative approach that leads to a
strategic vision of how to deal with upcoming safety challenges of synthetic
biology, to avoid biological accidents, legal uncertainties, and safety-based
public resistance. Adaptations may still be needed, but this time they
would be based on a solid framework.
The genetic firewall could at the same time improve industrial processes
and establish safer biosystems, but only if a collaborative action among
international scientists, policy makers, and other stakeholders can be
established.
Instead of resuscitating the limited concept of genetic suicide circuits,
scientists, safety experts, and policy makers may discuss radical
innovations as a strategic answer to upcoming biosafety challenges. The
pros and cons of xenobiology and the support and deployment of the
genetic firewall need to be discussed among international stakeholders.
Decisive action to radically improve future biosafety issues is required
from policy makers, concerned with the governance of biotechnology in
Europe and the United States, in the form of (i) support to the technical
development of a genetic firewall, and (ii) preparation of a regulatory
framework that details in which circumstances the genetic firewall has to
be deployed.
References
Marliere, P. (2009). The farther, the safer: a manifesto for securely navigating synthetic
species away from the old living world. Syst Synth Biol 3(1-4): 77-84.
Pei L., et. al (2012) Regulatory Frameworks for Synthetic Biology. Chapter 5 in: Schmidt
M. (ed.) 2012. Synthetic Biology: Industrial and Environmental Applications. Wiley-
VCH.
Schmidt, M. (2010). Xenobiology: a new form of life as the ultimate biosafety tool.
BioEssays. Vol.32(4): 322-331.
on Science for Global Policy (ISGP) December 47, 2012, at the Hilton El Conquistador,
Tucson, Arizona
Figure 1: DNA and XNA organisms would be able to interact on the level of whole
organisms but would not exchange genetic material through horizontal gene
transfer or via sexual reproduction (genetic firewall). Also, the XNA world needs to
be completely dependent on external supply of essential chemicals that it cannot
synthesize itself (XNA-auxotrophy).
Debate summary
not-for-attribution debate of the policy position paper prepared by Dr. Markus
Schmidt (see above). Dr. Schmidt initiated the debate with a 5-minute statement
of his views and then actively engaged the conference participants, including
other authors, throughout the remainder of the 90-minute period. This Debate
Summary represents the ISGPs best effort to accurately capture the comments
offered and questions posed by all participants, as well as those responses made
by Dr. Schmidt. Given the not-for-attribution format of the debate, the views
comprising this summary do not necessarily represent the views of Dr. Schmidt,
as evidenced by his policy position paper. Rather, it is, and should be read as, an
overview of the areas of agreement and disagreement that emerged from all
those participating in the critical debate.
Debate conclusions
Xenobiology, with its potential to reveal fundamental information about
biology and the origin of life and even life on other planets, is a potentially
transformative technology.
The regulation of xenobiology, especially with respect to the safety of its

procedures, its impact on human and environmental health and public
safety, and its toxicity, presents significant challenges. Although much
can be learned from the regulation of other biotechnologies, xenobiology
will likely have unique aspects concerning the creation of a foolproof
genetic firewall and the appropriate levels of physical and biological
containment.
Given the public concern over recent advances in genetic engineering,
including the public, policy makers, and legislators in discussions
characterizing the benefits and risks of xenobiology is critical to shaping
effective policy.
Concerns about public safety and security requires a level of governmental
control of xenobiology that may not be welcome by those who wish to
have open access to the technology and who promote its uninhibited,
rapid innovation.
Current realities
Xenobiology was generally acknowledged as an early-stage scientific field, which is
rapidly evolving. Although the assertion was made that xenobiology could create
a genetic firewall that would protect the natural environment from synthetic
organisms, this was strongly disputed. Given the extremely early stage of its
development, there are numerous unknown aspects of xenobiology related to its
safety, toxicity, and environmental interactions that were seen as potentially
dangerous. Although XNA may not be able to interact genetically with natural
DNA, XNA, or non-natural amino acids, may have a toxic effect on natural
organisms by interacting with the DNA replication machinery, or through immune
system effects. This would require additional layers of containment for any
xenobiology experiments or production. Xenobiology was not regarded as a perfect
firewall, and it was suggested that presenting it as such was an overstatement with
potentially harmful consequences.
The premise behind xenobiology was also questioned: Given that organisms
created via synthetic biology are already fragile, was there a need for xenobiology?
If xenobiology could be shown to be safe and commercially viable, it could be a
transformational technology.
Much of the debate centered on the appropriate way to regulate a new
technology such as xenobiology under current regulatory frameworks. Historical
parallels were drawn to the introduction of other major technologies, such as the
automobile or the airplane, where safety guidelines took some time to catch up
with the demonstrated capabilities of the technology. To avoid similar lags in
ensuring safety, it was proposed that regulations for xenobiology be implemented
in advance. The key component in providing effective regulation is assessing risk,
and while it is difficult to foresee all risks associated with such a new technology,
several proposals were made (e.g., gaming, modeling exercises, risk registers) for
methods to examine potential outcomes. Asking the right questions, and continuing
to ask questions as the technology progresses, were seen as critical to accurately
assessing risk. Carefully constructing a robust risk assessment framework was
considered to be a more effective approach than regulation through legislation or
government regulation alone. However, it was acknowledged that the complexity
of xenobiological systems would make assessing their potential impact challenging,
and require extensive testing and re-evaluation.
The public security questions involve determining who can be trusted to
work on or have access to information about organisms derived from xenobiology,
particularly if the fears about toxicity or autoimmune responses were realized. The
potential validity of these concerns were acknowledged, but not seen as especially
different from challenges being faced by the synthetic biology community, or for
any other new, potential dual-use technology.
There was disagreement over whether conducting research into xenobiology
would divert attention or resources away from research into proven, well-known
natural DNA, RNA, or protein systems. Many technical issues remain to be resolved
in these areas, including through synthetic biology, and proposing a shift toward
xenobiology may distract from these efforts. However, industry is already doing
xenobiology and will continue to do so. A particularly attractive aspect of
xenobiology for industry would be the ability to switch off an engineered organism
as a way to protect intellectual property (IP).

Many of the challenges posed for xenobiology are the same as those being faced by
synthetic biology. There was concern that the discussion was being framed as the
two technologies in opposition to each other, whereas given the similarities between
them, coordination would be more productive perspective. Creating division
between the two may provide an opportunity for opponents of biotechnology to
divide and conquer and limit progress in both fields.
A significant opportunity from xenobiology is the potential to provide
information about fundamental questions of biology. If xenobiology shows that
living organisms can be built with material other than the naturally occurring four
bases of DNA, the three base codon, or the naturally occurring 20 amino acids, the
basic concepts of the origins of life would be challenged. Additionally, information
gleaned from xenobiology research could provide details about how life evolved
on Earth. Space agencies in the U.S. and Europe have taken a particular interest in
xenobiology because of the potential to inform the search for life on other planets
(exobiology). In the anticipation that life may one day be found elsewhere in the
solar system (or universe), agencies such as the National Aeronautics and Space
Administration (NASA) are using xenobiology as a model to determine how any
extraterrestrial life should be handled (i.e., containment, worker protections, safety
protocols) if it can be returned to Earth. There are also resultant issues about how
to communicate with the public about any changes to our fundamental
understanding of life, either as a result of xenobiology or exobiology.
Safety concerns around xenobiology were viewed as a significant challenge.
Questions were raised concerning how organisms created via xenobiology would
interact with other natural organisms in the environment, what effect (if any) these
organisms would have on humans, whether these organisms or their products would
bioaccumulate in the environment or be degraded, and how readily would they
spread? Answers to these questions would be critical to making accurate risk
assessments, but it will be challenging to test each parameter safely. Particular
examples included the difficulty of assessing effects on humans with existing rodent
models, and the published autoimmune reaction to some types of xenobiology
products. Assessing these risks in theory or in silico is unlikely to be adequate.
The implication that xenobiology could provide a foolproof safety system
for synthetic biology was also seen as problematic. It was stated repeatedly that
nothing should be regarded as foolproof. Because it would be unwise to rely solely
on xenobiology to contain a synthetic biological organism (i.e., prevent it from
interacting with the environment), other physical containment systems would be
required. In this respect, xenobiology likely would not alleviate many of the
concerns around synthetic biology escaping from the laboratory or fermenter to
interact with the environment, as it would be difficult to definitively test such
interactions in advance of an escape. As a first step, preparing a detailed plan for
evaluating and testing each aspect of the release (intentional or accidental) of a
xenobiological organism would be important to provide some comfort to those
worried about potential adverse effects on the environment or human health.
There were concerns expressed about the potential for industry to monopolize
this technology as a way to simply protect its intellectual property. The example of
terminator technology, or genetic use restriction technology (GURT), was raised.
This technology would prevent farmers from using second-generation seeds from
genetically engineered plants, hence protecting the IP of the company that created
the plant. A similar situation could occur with xenobiology, with the public and
citizen scientists denied access to the technology should it be developed by big
industry. This would raise a number of political, social, and ethical issues, and
potentially lead to a backlash against xenobiology, similar to what occurred with
agricultural biotechnology, especially in Europe.
A significant challenge in advancing xenobiology is the extent to which the
public should be included in discussions about costs and benefits. The question
remains as to how much effort should be devoted to acquainting the public with
the terminology, potential, and pitfalls of the technology. The role of mass media
(e.g., movies and documentaries) was raised as an illustration of how xenobiology
could be presented to the public, either in a positive or negative light. The ability
to use these media to either enhance public understanding and support, or seed
fear in the public and lead to calls for limits or moratoria on research, were
considered. It was felt that the public should be included in the discussion about
xenobiology from the outset. Although there was the potential for creating a
backlash, trying to exclude the public from the discussion would likely be more
detrimental in the longer term. Achieving a positive outcome (i.e., having the
public assess the technology in a rational way), would depend on the types of
outreach and inclusion employed. It was generally acknowledged that public
discourse about this subject would be difficult.
Policy issues
Preparing governance structures for xenobiology was presented as a challenging
task, given the early-stage of the technologys development. It was acknowledged
that excitement alone is not enough to warrant significant investment in the field.
The field of xenobiology would need to mature before concrete progress could be
made on regulatory systems. However, it was noted that xenobiology is already
starting to show promise from a research perspective (e.g., using organisms to crack
hydrocarbons, building enzymes from nonnatural amino acids, constructing a six
base pair DNA to aid in HIV diagnosis). Some of these applications, although still
at the demonstration stage, are particularly exciting because the reactions they
catalyze cannot be performed in natural biological systems. Projects such as the
European Unions Metacode program are already investing in such applications.
A substantial portion of the discussion involved the nuances of regulatory
policy and how to apply different approaches to xenobiology. The regulatory
guidance for synthetic biology as it stands in the U.S. is relatively unclear, and
certainly not prescriptive in terms of conducting meaningful risk assessments.
Specifically, the guidance for synthetic biology research has been issued by the
Office of Biotechnology Activities (OBA), which suggests that risk from a genetic
element should be considered the same as the risk posed by the organism from
which it came. This leaves a significant gap, as many synthetic biology genetic
elements may be derived from no organism at all. Thus how can risk be
meaningfully assessed?
This problem would likely be even more relevant in xenobiology, where the
very components of such an element are completely new. There were some
suggestions that approaches and analyses could come from the engineering field.
While it was emphasized that asking the right questions was important, the issue
of how to regulate such an unknown technology was largely left unanswered. Views
differed as to whether the approach should be anticipatory (i.e., through regulation
enacted in advance) or dynamic (i.e., by continually asking questions to shape the
response).
Governance of xenobiology through self-regulation also was suggested. Some
felt this term to be problematic, as it might suggest an unwillingness to have
oversight from outside the community, so the alternative term safeguards was
proposed. A project in 2007 examined attitudes of European scientists toward
different governance approaches, and self-regulation was not a popular course of
action, in contrast to the preference of U.S. scientists. This highlighted the need to
provide culturally appropriate governance mechanisms.
Questions were raised as to who should control such genetic firewall
technology. Specifically, it was proposed that such a powerful and potentially
dangerous technology should remain under government control, although this
would raise issues as to who should be given access and under what circumstances,
and which governments should have control. Xenobiology, it was countered, needs
to be an open source, publicly available resource, as this would allow for the greatest
impact as a safeguard against misuse. Control and access are ultimately political
issues that will need to be resolved at the political level.
Given the difficulty in communicating xenobiology to the public, there also
would be issues concerning how to regulate xenobiology in communications with
policy makers. It was cautioned that being seen to be asking for early regulation
could result in overly restrictive controls, especially if the distinction was not made
effectively among regulation, guidance, and frameworks. It was agreed that
communicating this science effectively would be a key policy challenge as the field
progresses.
Comments suggested that existing safety regulations were obsolete for dealing
with a technology such as xenobiology. Regulatory systems vary widely among
different countries, and some nations, such as the U.S. and Australia, were viewed
as having quite robust systems in place. Much could also be learned from the
pharmaceutical sector, particularly in the area of self-regulation. Pharmaceutical
companies have been dealing with the need to ensure safety for new products for a
long time, and there may be lessons that can be extrapolated to xenobiology.
Policy Innovation in Synthetic Biology Governance**

Leili Fatehi, J.D., Research Fellow, and
Jennifer Kuzma, Ph.D., Associate Professor,
Humphrey School of Public Affairs, University of Minnesota,
Minneapolis, Minnesota, United States
Summary
Governance for synthetic biology (SB) is a topic of current policy discussions. This
paper argues that the framing of the governance debate is overly simplistic in
practice and theory, and thus governance is lagging behind technological
innovation. It calls for innovation in governance to match technological
innovation. To do so, three specific approaches are suggested. First, in the practical
realm, SB has not been appropriately unpacked for meaningful conversations about
governance. Disagreements in governance often arise from different
conceptualizations of what SB is. In this article, the development of a typology
(aka a classification system) of SB applications is suggested to move governance
discussions from the very general to more nuanced, actionable items. Second, in
the theoretical realm, framing SB governance as a continuum of approaches, rather
than a dichotomy, is recommended to allow for stakeholders to express different
values, but transcend the old, contentious, and unproductive debate over precaution
versus promotion. Finally, because SB will change and develop rapidly, governance
should be dynamic. Decisions about movement along the continuum should allow
for more responsive governance and better opportunities for compromise among
stakeholders with divergent opinions. However, these discussions should not be
left only to those developing or regulating the technology, as they do not hold all
the requisite expertise. A more diverse set of stakeholders and citizens with local
knowledge and expertise need to be included.
Current realities
SB has made the transition from science fiction to reality. A minimal cell has been
produced; undergraduate students use SB to make bacteria do novel things such as
smell like bananas or take pictures; people are developing SB in their own homes;
and the field is taking off in labs and markets. What remains is a sensible plan for
governance. Currently in the United States, agency hands are tied by ambiguity of
the SB field, politics, a lack of resources, and the fixation on decision-making based
solely on the natural sciences. In addition, the science is young, especially the risk
science needed for input into decisions. Moreover, current laws do not seem to be
enough for safety evaluation of new and emerging products of SB, as they are already
challenged by genetically engineered (GE) organisms. For example, GE insects
pose an interesting case where the Food and Drug Administration (FDA) may
regulate them as new animal drugs. Questions arise such as: How can a GE insect
be a drug? What expertise does the FDA have in ecology and ecological risk analysis?
What goes unchecked with this jurisdictional arrangement? In another example,
the Environmental Protection Agency (EPA) is responsible for genetically
engineered microbes (GEMs) under the U.S. Coordinated Framework for the
Regulation of Biotechnology using its regulations under the Toxic Substances
Control Act (TSCA). These regulations, however, do not cover intrageneric
organisms (i.e. GEMs with engineered genes from the same genus). One could
overexpress several bacterial toxins via SB in a GEM without U.S. regulation. This
GEM could be deployed in the environment to perhaps remediate pollution in
soils without oversight. Confidence in the U.S. regulatory system is affected by
such regulatory loopholes.

The technology has moved rapidly, but governance is lagging, especially for
environmental applications like those mentioned above. While policy discussions
about SB governance have increased over the past five years, the focus has largely
been on biosecurity, publication standards, and DNA synthesis security standards.
The publication of the H5N1 research describing how to make a hybrid virus that
moves from mammal to mammal received much public attention. Medical
applications of SB have received some attention from policy scholars (e.g. bacteria
engineered to fight cancer); however, agricultural and environmental applications
of SB have received almost none. These applications come with very different
portfolios of risk and benefit issues, ethical dilemmas, and socioeconomic impacts.
The agglomeration of sectors and issues related to SB stifles progress in SB
governance
Another problem stifling progress in the debate on SB governance is the
precaution-promotion dichotomy. For example, precautionary thinkers (such as
some ecologists, risk scientists, and consumer and environmental groups) and
technology promoters (such as some bioscientists and biotechnology companies)
have rigorously debated the oversight of GE organisms with little consensus built.
The contested climate has sparked lawsuits by consumer organizations against
companies or the U.S. Department of Agriculture (USDA) over the adequacy of
environmental assessments, affected markets for products, and impacted trade.
Policy issues
With SB products just beginning to enter markets, now is the time for
anticipatory governance exercises that engage stakeholders and the public
upstream of SB technological deployment. These exercises should provide
a forum for diverse stakeholders to come together on neutral or balanced
grounds and provide real opportunities for nuanced discussion and input
into decision-making. Stakeholder and public deliberation has been
demonstrated in case studies to improve the quality of decisions (NRC
1996). Engagement with real input into decisions, if done well, has been
shown to increase legitimacy, bidirectional learning, and mutual respect
among stakeholders. Furthermore, it is the right thing to do: in a
democracy, people paying for a service have the right to be informed, be
heard, and make choices about that service. Indeed, taxpayers fund the
majority of SB research in academe and also pay for subsequent discoveries
in industries that are based on publicly funded science and, therefore,
should have input into SB governance.
In the past, most discussions about governance of emerging technologies
have been largely limited to the science. However, by necessity, values
underlie conversations about governance and it is crucial that governance
discussions engage stakeholders on a broader range of ethical and societal
issues.
There is a need to unpack and to develop a typology for diverse SB
applications to move governance discussions from the very general to
more nuanced, actionable items. Policy debates currently fail to
differentiate between specific applications of SB. However, social science
research indicates that the public is unlikely to uniformly accept or reject
SB and public polling indicates that the public is able to distinguish among
SB applications. In our own work with nanotechnology and food
applications, we found that participants in public forums care about the
purpose of the technological product, the point of deployment, and the
risk/benefit distribution. To facilitate meaningful discussion about SB
governance options, we need more specificity. We have previously
developed a typology for SB products based on sector of application
(human medicine, consumer products, energy, food and agriculture,
chemical production, or environmental application) and technology type
(non-living biological parts, systems of non-living biological parts, highly
engineered cells, highly engineered systems of living cells, artificial living
cells, or systems of artificial cells) (Kuzma and Tanji 2010). Here, a third
dimension is suggested: technological purpose (improve human health,
improve environment, improve economic well-being, improve social well-
being, national security, enjoyment/entertainment, education, etc.). The
purpose dimension might be broken down differently, dependent on the
sector.
SB governance should be framed as a continuum covering preventive,
precautionary, permissive, and promotional approaches. This continuum
framing would allow stakeholders to transcend the old, contentious, and
unproductive debate over precaution versus promotion. In prior work
(Kuzma and Tanji 2010), we identified four governance policy areas
(biosafety, biosecurity, ethics, and intellectual property) in which this
continuum operates, with further differentiation based on the sector and
type of SB technology. For example, for artificial systems of living cells
released into the environment for food and agricultural applications, a
preventive approach may be the first choice for biosafety reasons; whereas,
for non-living biological parts used for biofuel production in the lab, a
highly promotional approach may be the first choice given fewer concerns
about biosafety. It is suggested here that even more nuance be added to
this framework as particular SB applications are considered.
Currently, oversight systems are almost static and, in the absence of crisis,
it takes years or decades for statute or regulation development. SB requires
the development of a new governance system that is dynamic and able to
consider and adapt to significant new data and information as they emerge
(i.e., advances in technology, biosafety, biosecurity, socioeconomic
impacts, law, or ethics). While garnering the political will for such a system
may take years, it will save us time and resources and promote better
decisions in the long run. We suggested a similar dynamic system in the
context of nanobiotechnology with principles of responsiveness, inclusion,
and anticipation in previous work (Ramachandran et al. 2011). For
products yet to hit the market, initial approaches to governance would be
considered according to the typology and continuum analysis described
above. As new information arises, a regulatory advisory group of
stakeholders would convene to consider changes in governance from more
to less preventive, or from mandatory to voluntary programs, or vice versa.
References
Kuzma, J. and Tanji, T. (2010). Unpacking Synthetic Biology for Oversight Policy.
Regulation & Governance 4:92-112.
National Research Council (1996). Understanding Risk: Informing Decisions in a
Democratic Society. National Academies Press: Washington, DC.
Ramachandran, G. Wolf, S. Paradise, J., Kuzma, J., Hall, R., and Fatehi, L. (2011).
Dynamic Oversight for Nanobiotechnology. Journal of Nanoparticle Research 13(4):
1345-1371.
Tucson, Arizona.
Debate Summary
not-for-attribution debate of the policy position paper prepared by Ms. Leili
Fatehi and Dr. Jennifer Kuzma (see above). Ms. Fatehi initiated the debate with
a 5-minute statement of her views and then actively engaged the conference
participants, including other authors, throughout the remainder of the 90-
minute period. This Debate Summary represents the ISGPs best effort to
accurately capture the comments offered and questions posed by all participants,
as well as those responses made by Ms. Fatehi. Given the not-for-attribution
format of the debate, the views comprising this summary do not necessarily
represent the views of Ms. Fatehi, as evidenced by her policy position paper.
Rather, it is, and should be read as, an overview of the areas of agreement and
disagreement that emerged from all those participating in the critical debate.
Debate conclusions
A more dynamic model applicable not only to synthetic biology, but also
to other scientific and technological advances with inherently high levels
of uncertainty concerning potential benefits and risk is needed. An
advisory body responsible for evaluating regulatory policies with respect
to transparency, public dialogue, and effective coordination within and
across agencies is essential for identifying a broad range of effective
governmental options.
While the feasibility of extrapolating domestic policies to the international

stage depends on the specific policy, an effort to apply best practices and
lessons learned, as well as to develop appropriately detailed modes, is
required to integrate policy decisions into different cultural and social
contexts.
Allocation of resources toward governance innovation, in addition to
funding the development of the scientific research, is a necessary short-
term spending priority to allow development of a more cost-efficient
system long term.
Current realities
Current governance structures allow for predictability, but serious inadequacies
have begun to be revealed in terms of their capabilities to cope with advances in
science and technology (S&T). Suggestions were made for new approaches to
governance and oversight, which were broader than regulations and comprised of
a full battery of options (e.g., ranging from soft to hard approaches), and were
made available to provide responsible and watchful oversight for a particular area,
such as synthetic biology.
There was disagreement as to whether the regulatory processes in place in
certain countries such as the U.S. and the United Kingdom were thorough enough.
In regard to the U.S., there was considerable disagreement on how strong current
governance structures were.
A distinction was made between horizontal and vertical approaches in relation
to technology and governance. Horizontal approaches refer to different regulatory
regimens, products, and techniques, while vertical approaches refer to predictions
for the future of the technology, such as potential changes. It was deemed important
to be aware of these dynamic scales in both directions.
The need to discuss regulation beyond the dichotomy of precaution and
promotion was raised. The precautionary principle could be considered in a more
nuanced, proportionate, and reasonable way, as opposed to simply preventing
scientific progress based on the elimination of all risks, and it was agreed that
precaution and prevention were not the same principle. These terms are often
mistakenly used interchangeably, and therefore inhibit a technology from advancing.
It was suggested that precautionary principle could be rehabilitated to describe an
approach that allows more time to collect more information rather than to delay
scientific progress. This was said to already be the case in existing U.S. regulations,
which are quite precautionary in nature, but concurrently there are cases where
the risk ratio is relatively higher in allowing applications to proceed.
There was debate over whether to differentiate regulation by product or by

process. The status quo of regulating by product was largely regarded as more
manageable and more likely to prevent unnecessary precaution. Switching to a
process-run system of regulation would require a significant overhaul that would
be costly, difficult, and time consuming.
Nanotechnology has set the precedent for a more dynamic approach toward
governance and for the use of softer methods (i.e., voluntary, guidance approaches)
to determine whether harder methods (i.e., legislation, enforcement) must be
subsequently implemented. The oversight of synthetic biology is being developed
based on the adaptive governance and interactive regulation (e.g., public dialogue)
approaches utilized for nanotechnology. The purpose of such approaches is to
optimize the outcomes of oversight, based on the absence of sufficient data and
scientific certainty.
Carrying out risk evaluations through various tools (e.g., modeling, gaming)
was emphasized as necessary prior to any policy development. However, it was
posited that decisions could still be made in the face of uncertainty and absence of
data, and that a dynamic system of governance could accommodate such cases.
While there may be a lack of coordination within and across different oversight
authorities, Canada was used as example of where coordination efforts have brought
regulatory bodies together to establish a process for defining regulatory roles for
new technologies. In regard to the U.S., the point was raised that perhaps more
coordination is happening than is believed (i.e., the relevant EPA, FDA, and USDA
officials do communicate with each other about synthetic biology) and particularly
concerning biotechnology.
It was emphasized that there exists an urgent need to define a framework
that can be invoked if a biosafety problem is reported. Following such a report,
there is normally a mandate to regulate unless it is found that all predetermined
agreements were correctly followed. Mandated regulations require rapid
implementation, particularly in the U.S. and Canada, with the result most likely to
be inappropriately heavy regulation.

There was considerable debate as to whether current regulatory systems were
obsolete, and concern was raised that novel systems to evaluate products and
processes might pose inherent risks by moving too quickly and making mistakes.
It was argued that a new dynamic system would not be applying approaches that
had not previously been tested, but rather would allow for a full range of hard and
soft governance options (i.e., from codes of conduct to top-down approaches) as
part of the governance structure. This would allow for an approach that can change
and adapt over time as new information is introduced.
While a dynamic model of governance may not prove to be very efficient,
especially with respect to public involvement, the model could allow for decisions
to be made early based on whatever information was available at the time. Soft-
approach regulatory decisions are already being made early on by stakeholders
and regulators and the concern was raised as to what extent certain bodies inherent
to the democratic process (e.g., the U.S. Congress) would potentially be asked to
relinquish their final decision-making rights.
The question was posed as to who would be responsible for regulatory
decisions made under the proposed new model. Although new (and likely
redundant) regulatory entities need not be created, an advisory board-type structure
could be charged with making recommendations along the dynamic continuum
of soft versus hard approaches to regulation, to be implemented by existing bodies.
The extrapolation to the international context of a framework developed for
domestic use could prove difficult. Thus far, the focus has primarily been domestic
policy, but the same lessons could translate internationally (e.g., models for decision-
making that set priorities and governance steps, such as better public engagement).
Therefore, the same lessons may apply despite the specifics of the regulatory
structure and whether it is domestic or international.
While international harmonization of product commercialization and its
associated processes for risk management may not be feasible because of differing
cultural contexts, it was argued that a standard model for deploying substances
worldwide can be developed that is fast, implementable, and repeatable. The
challenge will be to create a level of detail in the model that is able to accommodate
cultural and demographic changes.
There was disagreement regarding the communication among the scientific
community, third parties (e.g., NGOs), and the public. While such discussions
were not routinely occurring among groups who have a precautionary or
preventative approach toward governance (e.g., the ETC Group), a dynamic
continuum of governance could provide a way to have rational public discussions.
One challenge identified was prioritizing governmental spending on
innovation in a climate of limited resources. While it was argued that such spending
can be viewed as a luxury it was also recognized there are repercussions (e.g.
responding to crises) that are attributable to the absence of preventive measures.
In addition to institutionally derived constraints, the issue of cultural
constraints on policies is an additional challenge facing efforts to establish dynamic
governance. An example of a cultural constraint is the decision of the U.S.
Presidential Bioethics Commission to give practicing synthetic biologists the

responsibility for identifying potential societal risks. This decision delegated to
the scientific community was given the sole responsibility for characterizing the
societal risks associated with synthetic biology.
Synthetic biology has been described as not having been sufficiently
unpacked (i.e., defined), which was viewed as a point of frustration for both the
scientific and policy communities. Scientists have the technical expertise to help
policy makers understand the differences in risk parameters and draw appropriate
boundaries for acceptable levels of risk. The current concern is that regulations
will be drawn up arbitrarily without the evidence-based decision needed for
appropriate regulation. Therefore, there appears to be an incentive for scientists to
collaborate with policy makers in making decisions about technological applications
that raise novel risks, which require some sort of exceptional oversight as compared
with applications in which existing systems may suffice.
Policy issues
It was advocated that agencies must be proactive in evaluating the effectiveness of
existing regulatory structures and addressing more adaptive procedures for
governance where needed. Historical analyses have been carried out in certain
areas (e.g., medical devices, drugs, chemicals) in terms of comparing various
regulatory parameters (e.g., level of public input, and regulatory outcomes) to an
understanding of regulation development. This information was described as highly
valuable to agencies as it is used to make decisions for future approaches.
Having a system in place that allows changes in governance approaches as
more data emerges and uncertainty levels change was advocated as especially useful
for synthetic biology. This call for a paradigm shift in the governance of uncertainty
was echoed throughout the debate.
While it was agreed that some sort of coordination mechanism was needed
within and across regulatory agencies, regardless of the governance approach, the
structure for a coordinating entity remains to be determined. A formal body
representing different expertise across the relevant disciplines could be established,
including private sector stakeholders and the public. This type of forum has been
developed for nanotechnology, which was considered by some as analogous to
synthetic biology in that it also required a change in regulatory oversight. More
specifically, the National Nanotechnology Initiative (NNI) helped set priorities and
encourage communication across agencies, although it was not seen as
comprehensive example of what needs to be developed for synthetic biology.
Efforts at coordination could work within existing government frameworks.

For example, there exists a Memorandum of Understanding among agencies within
the U.S. Government (i.e. FDA, USDA, EPA), which funnels activities to the
appropriate body. It was suggested that there could be more deliberation and
interagency interaction. The framework is in place, but it is not effective with
emerging technologies such as synthetic biology. Improving the existing framework
could also address the issue of budgetary constraints in specific agencies. Addressing
interagency coordination through the Office and Management and Budget (OMB)
could result in improved efficiency and further policy within individual budgetary
constraints.
A minority point was made that the ability to develop synthetic biology
products for commercialization requires a set of manufacturing protocols for new
products that are likely to have little modification from existing, clearly defined,
and quality controlled manufacturing processes currently implemented for existing
products. This was described as being positive because synthetic biology should
not be viewed as an overhaul in current processes, but rather the effort should be
to ensure that the processes are fully vetted, transparent, and allow the technology
to be made available for real and beneficial applications globally.
Concern was raised as to how adaptive governance could incorporate public
engagement and deliberation in a representative democracy. Two alternative routes,
formal and informal, were proposed. First, develop a formal protocol for an intra-
agency committee representing affected stakeholder groups and the lay population
that is charged with making decisions about priorities. Second, implement various
public dialogues, based on existing models in Europe, the U.K. and elsewhere, that
involve citizen juries and public forums and facilitate dialogue between scientific
policy-making and the public.
Do-It-Yourself Biology: Reality and the Path

Toward Innovation**
Todd Kuiken, Ph.D.
Senior Research Associate, Science and Technology Innovation Program
Woodrow Wilson International Center for Scholars, Washington, D.C.,
United States
Summary
The United States has always been associated with innovation, particularly
individuals or groups of individuals designing and developing new ideas in their
garages and basements. As the Do-It-Yourself Biology (DIYBIO) community has
grown, so too has the concern surrounding individuals and groups tinkering with
biology. While much of this concern is overblown, the DIYBIO community is
better positioned than any other organization to develop a positive culture around
citizen science and to set the pattern for best practices worldwide by establishing a
code of ethics, developing norms for safety, and creating shared resources for
amateur biologists. U.S. policy should enable such exploration and innovation to
occur by eliminating barriers to government research funding, harnessing the power
of crowdsourcing, encouraging educational opportunities through community
laboratories and re-evaluating the current patent/intellectual property (IP)
structure for biotechnology and medicine. The question remains whether the U.S.
will enable and lead such exploration and innovation or restrict it.
Current realities
Today, thousands of people around the world belong to the DIYBIO community,
working on everything from microbial fuel cells, low-cost lab equipment, and
environmental surveillance, to personal biomonitoring and new treatments for
diseases. A more accurate term may be Do-It-With-Others Biology, as members
of this community engage among each other via a global list serve where they
exchange ideas, share experimental data, and discuss broader issues affecting the
community. While individuals and groups have long been tinkering with biology
outside traditional settings, DIYbio.org was officially created at a meet-up in Boston,
Mass., on May 1, 2008. DIYbio.org is an organization dedicated to making biology
an accessible pursuit for citizen scientists, amateur biologists, and DIY biological
engineers who value openness and safety. Since 2008, the global community has
expanded rapidly and now includes community laboratories, which may be the
future of DIY science expanding well beyond just biology.

Education. One of the major opportunities and current focuses of the DIYBIO
community is education. The U.S. has fallen way behind in terms of math and
science education. Primary school education curriculums in the U.S. contain little
to no biotechnology. Community laboratories are beginning to fill that void by
providing courses and hands-on experience in the fields of biotechnology and
synthetic biology. More importantly, they are providing the impetus and spark to
get the next generation of scientists, engineers, and innovators excited about science.
They also can provide opportunities for universities and community colleges that
may not have labs equipped for synthetic biology and other biotechnology
experiments. In 2011, Genspace, the first community laboratory to open in the
U.S., provided the lab space, equipment, and advisory role for an iGEM team
consisting of students from Cooper Union and Columbia University. In addition,
Genspace serves as a node for the Urban Barcoding Project to provide extramural
learning opportunities for New York City school children at the kindergarten
through 12th grade levels.
Personalized medicine. One of the first major stories about the DIYBIO movement
was when Kai Aull, a DIYBIO enthusiast, developed a genetic test for the hereditary
disorder hemochromatosis in her apartment in Boston. While commercial DNA
tests for hemochromatosis have long been available, she demonstrated that a genetic
diagnostic test could be developed in a makeshift lab, arguably for a much lower
cost than the commercial version. With the advent of new technologies that enable
diagnostics, monitoring, and drug delivery to move from a centralized (e.g., doctors
office, hospital etc.) to a decentralized paradigm, the ability of individuals to take
control of their health care with or without a doctor becomes more a reality.
Synthetic biology and DIYBIO techniques can potentially enable individuals to
design their own diagnostics and treatments (Munro, 2012).
Crowdsourcing. The heightened concern over bioterrorism, increased outbreaks
of diseases (e.g., SARS, avian influenza, West Nile virus), and food poisoning raises
the question of how best to monitor, track, and defend against such events. One
method may be to take advantage of the rapidly decreasing costs of sequencing
and the ever-increasing members of the DIYBIO and other amateur communities.
One such effort is the BioWeatherMap initiative: a global, grassroots, distributed
environmental sensing effort aimed at answering some basic questions about the
geographic and temporal distribution patterns of microbial life. The challenge
with crowdsourcing, particularly when dealing with biological and microbial
samples, is the verification and accuracy of such information. One could imagine
a person or node monitoring for a bacterium such as Bacillus anthracis and finding
a hit, which if not verified or put into the proper context, could cause a public
panic. However, the distributive potential of monitoring for biological threats is
enormous.
Spurring innovation. The DIYBIO movement has already created companies
producing low-cost equipment for individuals and community labs (Biba, 2012).
While no one can say for certain whether the DIYBIO movement will spur the
next game-changing technological breakthrough, the potential is there. However,
this will require mechanisms for amateurs to increase their knowledge and skills,
obtain access to a community of experts, develop a code of ethics, establish
responsible oversight, and assume leadership on issues that are unique to doing
biology outside of traditional professional settings.
Access
ess. One of the major challenges the DIYBIO community faces is access to
DNA sequences and parts, or biobricks. While the U.S. Department of Health and
Human Services (HHS) guidelines for DNA synthesis specifically state that gene
sequencing companies should not deny an order based on whether a person is
affiliated with a university-type laboratory, gene sequencing companies have shown
reluctance to fill orders coming from the amateur community. This reluctance is
understandable given the lack of understanding of the DIYBIO community and
the liability that a company may be under should something go wrong. However,
the HHS guidelines are just that, guidelines, and there is no U.S. law or regulation
that mandates to whom a company can or cannot sell. While certain sequences are
restricted based on the select agent list, there is still an open question as to whether
parts of those sequences would fall under the same rules.
Funding. One of the major challenges for the DIYBIO movement, and community
laboratories in particular, is acquiring the resources needed to establish and maintain
a working biotechnology laboratory. Even though the cost of sequencing
technologies is rapidly dropping, maintaining a working laboratory requires a
constant source of financing. While innovative methods and non-traditional fund-
raising such as Kickstarter have enabled the DIYBIO community to raise funds to
purchase or build their own equipment thus far, some federal agencies such as the
Defense Threat Reduction Agency have already begun to explore avenues to utilize
and fund the DIYBIO movement.
Intellectual property. Another major challenge for the DIYBIO community and
the larger synthetic biology community are issues surrounding IP rights and how
DNA sequences, biobricks, and genetic tests are patented. The recent Myriad
Genetics case seems to suggest that a persons DNA or specific component of that
DNA and the tests to analyze that DNA can be patented. What is more disturbing
for the DIYBIO community in particular is that it appears that one cannot design
a different testing method to analyze a particular gene or sequence. What Kai Aull
did in her apartment in Boston may have violated certain patents on the
hemochromatosis test.
Press. The misrepresentation and complete lack of understanding of the DIYBIO
community enables those with alternate agendas to use the community as a
scapegoat. While there are biosecurity and biosafety concerns associated with the
DIYBIO community, the press has by and large overblown those concerns. This
can create a false narrative for the general public on the true capacities and
motivations behind the DIYBIO movement.
Policy issues
Federal funding agencies should develop metrics and procedures to allow
actors outside the traditional academic or business communities to apply
for and receive federal grants. If we want to harness the intellectual power
of this movement, federal funding agencies should rethink their
mechanisms for awarding grants. There is no reason why a community
laboratory or an individual should not be able to apply for and be awarded
federal research grants.
Biosecurity and biosafety surrounding the DIYBIO community should
continue to be evaluated. Building upon the Federal Bureau of
Investigations (FBI) outreach program, other federal agencies, along with
local law enforcement, should be better trained and engaged with the
DIYBIO community to understand and utilize the community for
biosecurity monitoring. One method may be to take advantage of the
rapidly decreasing costs of sequencing, use of mobile technologies, and
the ever-increasing number of members of amateur science communities.
The distributive potential of monitoring for biological threats is enormous.
Access to DNA sequences should not be limited to actors from traditional
academic and industrial laboratories. However, screening guidelines
should be strengthened and shipping and export control laws updated to
incorporate pieces and components of DNA. This incorporates multiple

agencies and an interagency task force should be established with the
flexibility to update the guidelines alongside the pace of the technology.
Patent law regarding DNA sequences and synthetic biology parts should
be re-evaluated. The advances in synthetic biology and the advent of the
DIYBIO movement enable more ubiquitous access to components of
DNA. These patent issues will grow more complicated as personalized
medicine and the ability of individuals to sequence their own DNA
become more readily available. The question becomes whether the IP
structure, government regulatory system, and the public will enable it to
happen.
References
Munro, D. (2012). Biohacking healthcare - Part 1, Forbes Magazine. Retrieved from
http://www.forbes.com/sites/danmunro/2012/09/13/biohacking-healthcare-part-1/
Biba, E. (2012). Genome at home: Biohackers build their own labs. Wired. Retrieved
from http://www.wired.com/magazine/2011/08/mf_diylab
Tucson, Arizona.
Debate Summary
not-for-attribution debate of the policy position paper prepared by Dr. Todd
Kuiken (see above). Dr. Kuiken initiated the debate with a 5-minute statement
of his views and then actively engaged the conference participants, including
other authors, throughout the remainder of the 90-minute period. This Debate
Summary represents the ISGPs best effort to accurately capture the comments
offered and questions posed by all participants, as well as those responses made
by Dr. Kuiken. Given the not-for-attribution format of the debate, the views
comprising this summary do not necessarily represent the views of Dr. Kuiken,
as evidenced by his policy position paper. Rather, it is, and should be read as, an
overview of the areas of agreement and disagreement that emerged from all
those participating in the critical debate.
Debate conclusions
While DIYBIO has great potential for innovation and education,
particularly with regard to fostering curiosity about science in younger
generations, the potential for nefarious applications of the technology
raise security concerns, especially for the DIYBIO community, which itself
might be at risk from those with nefarious intentions. Appropriate
mechanisms are being established to facilitate the reporting of suspicious
behavior or activity.
The DIYBIO community has voluntarily made efforts to ensure safe
operations by investing in the establishment of DIYBIO community
laboratories. While biosafety boards have been established and experts
consulted to ensure certain standards of safety, there are no requirements
for DIYBIO practitioners to adhere to those rules. There is considerable
concern regarding future compliance as the DIYBIO field evolves and
practitioners engage in riskier experimentation.
Because DIYBIO is rapidly progressing and attempts to prevent or delay
the movement will likely be circumvented, it is critical that an effective
system of oversight be established that encourages the sharing of
information and open access to experimental results.
Community colleges can provide suitable forums for facilitating the
oversight of DIYBIO using methods that provide benefits for both the
DIYBIO community and society in general. Such an oversight, however,
must ensure that diverse types of DIYBIO experimentation, ranging from
individual work to participation in community laboratories, remain
generally available to qualified practitioners.
Current realities
To address biosecurity concerns, various regional groups from within the DIYBIO
community have met to develop codes of conduct and best practices for DIYBIO
operations. Creating an open and shared community with mechanisms in place to
recognize and report attempts to utilize DIYBIO for nefarious purposes was deemed
important to support a productive future for the DIYBIO community. A good
working relationship exists between the DIYBIO community in the United States
and the FBI, which monitors potentially nefarious and unsafe uses of the science.
In addition, many members of the DIYBIO community have cultivated
relationships among community, local, and state emergency first responders. Local
authorities have not yet sought to regulate DIYBIO through local ordinances, but
efforts to impose such oversight can be anticipated soon.
The FBI also has accepted responsibility for educating community groups
on acceptable thresholds of DIYBIO experiments and for what types of materials
should be made available to conduct them. The FBIs outreach to the DIYBIO
community was described as one aimed at protecting the community from real-
world threats (e.g., those with nefarious intentions seeking knowledge or
instruction) by promoting cooperation with local law enforcement. Community
contacts (e.g., local law enforcement, building inspectors) also have been provided
so local information (e.g., required adherence to codes, fire, or safety measures)
relevant to proper oversight of safety as community laboratories are developed.
It was noted that the DIYBIO community strives to operate under the safest
practices possible and certain groups (e.g., Genspace, Biocurious) have established
biosafety advisory boards that must approve projects prior to their commencement.
Such approvals often are based on meeting prescribed standards of safety. Because
developing a working laboratory that emulates standards of a university laboratory
requires large investments of time and money, stakeholders in community
laboratories are motivated to promote safety to protect their investments. The
DIYBIO community has partnered with the American Biological Safety Association
(ABSA) to launch a program that addresses operating safety questions (e.g., how
to best dispose of experimental starting materials and products, or how to know
whether equipment was decommissioned properly and is safe to use in new
experiments). These guidelines are being implemented and could be considered
more stringent than regulations in university laboratories.
The DIYBIO community is developing links with biosafety officers to teach
best safety practices and foster ongoing dialogues as the technologies develop.
However, it was noted that regulations requiring adherence to best-practice or safety
recommendations do not generally exist and cases were cited in which advice from
biosafety officers was not heeded. While it was argued that improvements have
been made in following best-safety practices, it was recognized that there would
always be outliers. The ideas that emerged from the two DIYBIO organized
congresses (one in Europe and one in the U.S.) were similar with respect to attitudes
on open access and safe operating practices, indicating a unity of thought in the
global DIYBIO community.
Many DIYBIO community labs have agreed to operate at Biosafety level 1
(BSL-1), but it was predicted there will be efforts to operate at BSL-2, which involves
agents of moderate potential hazard to personnel and the environment. Such a
change will require addressing additional biosecurity concerns which are not yet
fully understood by the DIYBIO community. While any BSL-2 experimentation

with pathogens poses significant safety concerns, it was noted that there is no known
work with pathogens being performed in the DIYBIO community.
The technical capabilities of the DIYBIO community are not as advanced as
the level implied by some elements of the media (e.g., linking DIYBIO to potential
release of engineered H5N1 influenza virus). Even if such technical capabilities
existed, any dangerous uses would be considered criminal activity, and any
individuals with nefarious intentions would not be included in or supported by
the DIY community.
Skepticism was expressed regarding the use of the term community to
describe those participating in DIYBIO, since many practitioners undertake
synthetic biology outside organized groups or laboratories. Federal endorsement
for this community (i.e., through grant awards) could have repercussions, including
perceived validation of what could be considered a free-for-all science.
It was noted that individuals who had been conducting experiments on their
own are trending toward more collaborative efforts at community laboratories.
This trend was attributed to limitations in working individually or in smaller groups
and the perceived advantages of participating in community laboratories (e.g.,
access, group work, better equipment). While models of operation, codes of
conduct, and safety consultation programs have been developed to aid those who
are engaging in DIYBIO in community laboratory settings, it was considered
important to implement programs for those conducting experiments outside of
formalized groups.
Concerns were raised that some level of control and freedom would be lost if
community college laboratories were utilized. While there would be positive
implications for college recruitment, there would need to be acceptance from the
community and controls to assure safety. It was mentioned that different groups
within the DIYBIO community could have different levels of willingness to accept
federal funding if it altered whether they would still be classified as DIYBIO.

One perceived benefit of the DIYBIO community was increased public acceptance
of advances in science (e.g., GMOs), which would be particularly useful in Europe.
Community laboratories provide a niche that allows younger generations to
experiment and therefore, serves a critical role in public education that university
laboratories likely could not offer. Targeted outreach to a younger demographic
group could foster a generation that is more aware of the advances in synthetic
biology and science in general and thus, is more likely to view these advances
favorably.
The existence of community laboratories outside the regulatory structure
was debated. Since community laboratories in the U.S. and in Europe are partnering
with universities to receive permits for genetic experimentation, it was suggested
that regulated laboratories could be established for members of the DIYBIO
community.
Because regulations can be circumvented as has been seen in other areas (e.g.,
drug trafficking, pirating), attempts to prevent or delay DIYBIO were described as
futile. Restrictions also could result in a technological shift to less-regulated
countries (e.g., Brazil, India). A survey of the larger groups regarding their attitudes
toward an oversight system would be helpful in understanding what would be
required to ensure that experimentation continues to occur openly and is not driven
underground. The potential of the DIYBIO community to move to BSL-2 was
described to be of serious concern and therefore requires external oversight. While
the DIYBIO community laboratories likely will be regulated, it would not be possible
to regulate individual experimentation outside of a community laboratory.
The DIYBIO communitys endorsement of developing nonstandardized
synthetic biology diagnostic testing (e.g., testing for a genetic predisposition) was
of concern, given the number of people who have suffered adverse consequences
from such amateur efforts (e.g., not seeking treatment for a false negative result).
Proponents for the development of DIYBIO diagnostics argued that such activity
would not bypass diagnostic systems developed through medical establishments,
and such efforts primarily are motivated by personal curiosity about such tests.
The real challenge of DIYBIO diagnostic testing is how the medical establishment
approaches those who have self-diagnosed. Diagnostic testing was described as a
continuum that was moving toward home testing and personalized medicine.
However, while formally developed home tests follow standards, DIYBIO
diagnostics likely would continue to be developed standards were put in place or
not. It was noted that most community laboratories do not allow for diagnostics
development, and therefore, a distinction needs to be made between more visible
and established community laboratories, and individuals working in private.
Policy issues
It was argued that an oversight system for DIYBIO could be created at the state or
local level, but was far more likely to exist at the state level. Basic oversight would
include a licensing system that certified some level of competence prior to allowing
practice, similar to driving a car.
There was concern that community laboratories are able to perform

experiments without the approval process required for other scientific groups. The
current regulatory system requires an approval system that is compatible with the
realities of experimentation, and places boundaries on what DIYBIO groups are
experimentally initiated.
Future liability related to DIYBIO endorsement of certain practices (e.g.,
developing diagnostics that could present false negatives or false positives) was
weighed against the potential educational benefit that DIYBIO could provide. Calls
were made for an immediate analysis or review to prevent threats that could create
demands from the public to terminate the DIYBIO community and for the
development of a framework to deal with any potential threats.
While biosafety advisory boards have been implemented in some DIYBIO
settings to ensure safe operations and bolster public confidence, it was agreed that
some mechanism or policy must be developed to limit liability in the case of genuine
mistakes. In addition, the DIYBIO community should not be held responsible for
someone outside the community (but practicing DIYBIO) engaging in criminal
activity. Backlash against such an action could lead to excessive regulations to
counter the increased perceptions of risk.
The DIYBIO community was characterized as a network of responsible
individuals, many of whom come from International Genetically Engineered
Machine (iGEM) competition teams. Some of the community consists of amateurs,
but the majority are leaders in the field. The future success of the DIYBIO
community would require continued mentorship and guidance from these leaders.
A main issue raised was whether governments should fund DIYBIO.
Government funding comes with the responsibility that taxpayer money is spent
on projects that are consistent with government policies and priorities.
Requirements in the form of regulations and qualifications are routinely attached
to federal funding to prevent inappropriate spending. Government funding or
grants for DIYBIO could be formalized for the purpose of utilizing the educational
benefits provided by DIYBIO community (e.g., use of community laboratories as
a node to teach more people about biotechnology). Even a small grant (e.g. $5,000)
would be useful for many community groups (e.g., Genspace).
It was widely agreed that community colleges were appropriate venues for
overseeing and controlling the creation of community DIYBIO laboratories that
might qualify for certain types of government funding (e.g., National Science
Foundation grants). Such funding might not require the same restrictions that
university laboratories have concerning who can participate (i.e., enrolled students
only). Community colleges conversely might be interested in partnering with the
DIYBIO community to gain equipment that could improve technician-training

courses.
It was agreed that the DIYBIO community should register with a federal
department to prevent illegal experimentation (e.g., working with pathogens).
Registration could also improve access to types of materials for the DIYBIO
community. Mechanisms could be implemented to encourage registration and
prevent unregistered experimentation.
It was suggested that a peer-review system is needed to address the quality of
results from DIYBIO experimentation. Such peer review would help prevent flawed
testing or unsupportable results from being published. While there are mechanisms
for testing validity within the DIYBIO community, it was agreed that there is no
system in place to verify DIYBIO experiments outside of the community.
Controlling potential propagation of noncertified results was deemed important
for future consideration.
Governance of Synthetic Biology**

Robert M. Friedman, Ph.D.
Chief Operating Officer and Professor, J. Craig Venter Institute,
San Diego, California, United States
Summary
Synthetic biology is biotechnology. From a policy perspective, synthetic biology
is a new set of methods for genetic engineering that offers new opportunities, brings
several new challenges, and just as important, does little to alter the controversies
that have surrounded the use of biotechnology for the last several decades.
I will first review the current governance of synthetic biology and
biotechnology to address five key societal concerns: 1. biosecurity, 2. laboratory
biosafety, 3. harm to the environment, 4. human health, and 5. ethical issues. I
then briefly discuss the potential benefits and risks to society, and finally, present
some governance options for policy makers to consider.
Current realities
Over the past eight years, the J. Craig Venter Institute (JCVI), in collaboration with
several other institutions, has examined a broad range of societal issues raised by
synthetic biology with a view to disentangling the set of concerns that are either
unique to synthetic biology, or where the use of synthetic biology significantly
adds to societal concerns about the use of biotechnology in general. Our goal
has been to identify governance options that address the new issues raised by, or
significantly changed by, this next-generation biotechnology. To provide context,
I will first review current governance of synthetic biology in the United States.
Biosecurity was the first societal concern related to synthetic biology to reach the
attention of policy makers, beginning with the synthesis in 2002 of an infectious
polio virus constructed in the laboratory directly from nucleic acids by Eckard
Wimmer and colleagues. The paper demonstrated for the first time in a post-
September 11 world the feasibility of synthesizing a complete human pathogen
using only published DNA sequence and mail-ordered raw materials.
Over the following decade, two governance activities have been most
significant. In 2004, the U.S. National Institutes of Health (NIH) established the
National Scientific Advisory Board for Biosecurity (NSABB), a federal advisory
committee chartered to provide advice about dual-use biological research (i.e.,

legitimate research that might also be misused for nefarious intent), including
synthetic biology. The NSABB functions at the national level; there are no
requirements for individual research institutions to establish mechanisms to review
the dual-use implications of the research undertaken by their scientists, though
some do. In 2010, the U.S. Department of Health and Human Services (HHS)
published the Screening Framework Guidance for Providers of Synthetic Double-
Stranded DNA, with the goal to minimize the risk that unauthorized individuals
or individuals with malicious intent will obtain toxins and agents of concern
through the use of nucleic acid synthesis technologies. It is now standard practice
for suppliers of synthesized DNA to screen orders to see if they contain dangerous
sequences of concern and to make sure their customers are legitimate research
users.
Biosafety concerns related to genetic engineering research have been under the
purview of the NIH since 1976, when the agency first issued the NIH Guidelines
for Recombinant DNA Research. Though the NIH retains some oversight
responsibility at the federal level, most is delegated to Institutional Biosafety
Committees (IBCs) required at institutions that receive government funding. The
NIH Guidelines have been revised frequently since that time to stay current with
the evolving science. The next revision, which will take effect in March 2013, is the
first that will explicitly address synthetic biology research and will be renamed
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid
Molecules. Other than making clear the NIH Guidelines apply to research with
synthetic biology, as well as recombinant DNA, few substantive changes were made.
Commercial products that might cause harm to the environment or human health
are regulated by a long list of federal laws and regulations. The oversight and
regulatory framework in the United States for products developed using
biotechnology stems from the 1986 Coordinated Framework for Regulation of
Biotechnology. The Coordinated Framework assigned primary responsibility for
regulating the products of biotechnology to three agencies: the Food and Drug
Administration (FDA), the Animal and Plant Health Inspection Service (APHIS)
of the U.S. Department of Agriculture (USDA), and the Environmental Protection
Agency (EPA), using an array of laws in place at the time. Figure 1 summarizes the
products that are regulated, by which agency, and under what law, as well as the
societal risks addressed.
Ethical issues related to synthetic biology were reviewed by the Presidential

Commission for the Study of Bioethical Issues. The 2010 study, New Directions:
The Ethics of Synthetic Biology and Emerging Technologies, recommended that the
government remain forward-looking about the potential benefits and risks to the
public, but did not recommend that additional agencies or oversight bodies need
to be created to oversee synthetic biology.
Opportunities and challenges

Synthetic biology combines methods for the chemical synthesis of DNA with
computational techniques for DNA design. These new techniques have the potential
to accelerate scientific and technological progress in a variety of areas: from basic
research to understand how living cells function, to biofuels to power our cars, and
to high-value pharmaceuticals, including vaccines to respond quickly to emerging
threats.
However, these advancements present several new challenges. Synthetic
biology can be dual-use: in addition to useful advances for society, it provides those
with nefarious intent new ways to harm. Improvements in the speed and cost of
DNA synthesis are also opening the field to new participants (e.g., engineers and
computer scientists). This influx of new practitioners must be trained to work
safely in the lab.
The public will likely expect that any living organisms modified by synthetic
biology and intended for market will first be reviewed for possible adverse effects
to the environment or human health. Though the Coordinated Framework for the
regulation of products of biotechnology has been in place for more than 25 years,
it is still controversial. Known harms to the environment or human health from
introduced products have been minimal. However, some view our current system
as too lax, others as too burdensome. But two areas appear particularly challenged
by the new technology: many plants modified using synthetic biology techniques
may no longer be covered by USDA rules, and the increasing number and diversity
of microbial products that synthetic biology will enable will likely create a challenge
for the EPA.
Policy issues
Biosecurity
Current HHS Guidance for screening synthetic nucleotides applies to
providers of synthetic double-stranded DNA. Similar guidance could be
directed to providers of oligonucleotides (single-stranded nucleotides),

from which pathogenic viruses can also be constructed (though with
greater difficulty, and with greater technical challenges for affected
companies).
The currently mandated roles and responsibilities of IBCs could be
broadened to include review of dual-use research of concern. IBCs would
continue to carry out the duties outlined in the NIH Guidelines but with
review expanded to consider dual-use concerns.
Biosafety
NIH and the Centers for Disease Control and Prevention (CDC), which
currently publish the gold-standard lab biosafety manual, could prepare
a companion manual for biosafety in synthetic biology laboratories, geared
to the background and needs of the new generation of synthetic biologists.
Harm to the Environment

JCVIs ongoing review of the Coordinated Framework for Regulation of Biotechnology
has identified two key challenges:
USDAs current rules will not cover many plants modified using
synthetic biology techniques. Newer plant technologies, including
synthetic biology, will be less likely to use plant pests during the
transformation process and so largely will not be subject to the assessment
process that has been a staple of traditional biotechnology regulation.
Options to address this gap include:
No action: APHIS maintains a voluntary assessment process for
genetically modified plants, but review is required for only those
organisms with a potential to be plant pests.
APHIS incorporates its noxious weed authorities into biotechnology
regulation to add another significant risk to ecosystem health.
The increasing number and diversity of microbial products that
synthetic biology will enable will likely create a challenge for the EPA.
The Toxic Substances Control Act (TSCA), the primary law governing
commercial, genetically engineered microorganisms, was not intended
for this purpose and in the view of some, is ill-suited to be the primary
regulatory mechanism, particularly as the number of microbes requiring
assessment increases. Options to address these challenges include:
Congress ensures that the EPA is given sufficient resources to

adequately undertake the regulatory reviews needed to evaluate the
risks posed by commercial microbial products engineered using
synthetic biology techniques or, more aggressively, amends the TSCA
to strengthen the EPAs ability to regulate such microbes.
EPA develops a voluntary assessment process for noncommercial
microbes, which are currently exempt from regulation.
References
Garfinkel, M.S., Endy, D., Epstein, G.L., & Friedman, R.M. (2008) Synthetic Genomics:
Options for Governance. Rockville, MD: The J. Craig Venter Institute. Retrieved from
http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-genomics-report/
synthetic-genomics-report.pdf
Tucson, Arizona.
Debate Summary
not-for-attribution debate of the policy position paper prepared by Dr. Robert
Friedman (see above). Dr. Friedman initiated the debate with a 5-minute
responses made by Dr. Friedman. Given the not-for-attribution format of the
views of Dr. Friedman, as evidenced by his policy position paper. Rather, it is,
Debate conclusions
In general, the current governance framework for synthetic biology is
largely appropriate for the technology at this time, because even though
the definition of synthetic biology is still debated, the premise that it is
part of biotechnology is generally accepted
While the regulatory burden for the Environmental Protection Agency
related to products from synthetic biology is manageable in the near term,
it is critical that Congress acts to supplement the resources of the agency
or to augment its regulatory authority in the longer term.
The term synthetic biology, and specifically the word synthetic, has a
negative perception with nonscientists. While the term seems to be
entrenched and unlikely to change, scientists need to be sensitive to this
perception.
Because regulation of synthetic biology and its products necessarily spans
a spectrum of governmental agencies, there is a recognized need to create
interagency cooperation and communication.
Current realities
Significant discussions centered on the importance of understanding the historical
context of regulation of synthetic biology in the United States. Governance of
biotechnology dates back to the mid-1970s when the National Institutes of Health
(NIH) first issued the Guidelines for Recombinant DNA Research, with a focus on
laboratory biosafety and containment. In the 1980s, serious consideration of the
governance of the biotechnology products (and not just the process) was
undertaken. In 1986, the Coordinated Framework for Regulation of Biotechnology
was enacted, which assigns primary responsibility for the regulation of
biotechnology products to three agencies: the U.S. Food and Drug Administration
(FDA), the Animal and Plant Health Inspection Service (APHIS) of the U.S.
Department of Agriculture (USDA) and the U.S. Environmental Protection Agency
(EPA). In the 1990s, the Presidential Bioethics Commission was initiated to provide
a discussion forum and publication avenue for ethical issues raised by some of the
products of biotechnology.
Synthetic biology was recognized as bringing new regulatory and governance
challenges as compared with the more traditional recombinant DNA technologies.
Specifically in the field of biosecurity, the U.S. government established in 2004 the
National Science Advisory Board for Biosecurity (NSABB) to examine dual-use
biological research. In 2010, U.S. government guidance was issued to companies
that sell synthetic double-stranded DNA. Lastly, a new revision of the NIH
Guidelines that applies to both recombinant DNA and to synthetic DNA was
anticipated for release in March 2013. While there was consensus that these steps
represent significant progress, it was also agreed that there will always be new issues
surrounding synthetic biology to consider.
Clarification was requested on the details of the National Environmental
Policy Act (NEPA), which was written in the 1970s. It was explained that, although
the EPA came into existence at approximately the same time as NEPA, the agency
is not governed by the legislation. Thus, the need for EPA approval does not trigger
a NEPA analysis. However, undertaking any other major federal agency action
(e.g., building a bridge, building a road, or initiating a field trial for genetically
engineered mosquitoes) would require an environmental assessment. Within the
conditions of use section of the application prepared by the sponsor, the agency
evaluates the probability of a significant impact on the human environment in the
United States. Upon completion of this assessment, one of two alternatives is
generally taken. First, the agency can determine that there are no extraordinary
circumstances and grant categorical exclusion. Second, if it is ruled that there are
extraordinary circumstances (e.g. first of its kind, or the agency does not have
sufficient experience or expertise in the area), then an environmental assessment
may be required. At the end of that environmental assessment, a finding is made
as to whether there is a significant environmental impact. The agency also has the
option to release any environmental assessment as a draft for public comment.
The issue of communication among federal agencies prompted a suggestion

that a new agency may be needed for the review and approval of synthetic biology
products. A counter-proposal outlined the need to increase synthetic biology skills
within the agencies, as well as the need to increase interagency coordination and
communication. Genetically engineered salmon was an example of the need for
and the ability of agencies, particularly the EPA and the Fish and Wildlife Service,
to work together. A brief explanation of the Coordinated Framework for the
Regulation of Biotechnology, written in 1986, acknowledges that all the agencies
should regulate to about the same level of rigor if there is an action involved. Thus,
if an agency lacks sufficient expertise from within, it may declare another agency
as the lead agency with respect to statutory authority for making a decision. The
actual review team may also enlist experts from other agencies, which is what is
occurring with the review of genetically engineered mosquitoes.
Perceptions around terminology, specifically the word synthetic, were
acknowledged as being perhaps benign for scientists, yet having negative
implications for the general public and policy makers. A question was raised as to
whether it was too late to change the term, or re-brand the technology. Focus
groups have been assembled to gather reactions to the term synthetic biology
and these exercises were expected to generate reactions about playing God and
creating life. However, the focus group participants fixated on the word
synthetic, and linked it to synthetic chemicals, which were perceived as negative
and capable of destroying the environment and creating significant pollution.

Areas of societal concern, specifically human health and ethical issues, were
discussed. It was noted that the Presidents Commission on Bioethics (PCB) has
thus far chosen not to make any recommendations in this area. However, the PCB
also suggested that the use of novel synthetic organisms and cell therapies of mixed
microbial origins may have unanticipated or delayed immunological response
issues, as well as the potential for synthetic biology organisms to reproduce or
evolve. A new discussion about combining bioethics and engineering ethics, both
of which have a significant impact on human health aspects and on new ethical
issues, may be useful.
The increasing number and diversity of microbial products that synthetic
biology will enable, and the concomitant regulatory challenges that this increase
presents for the EPA was discussed. Possible solutions include that Congress ensure
that EPA is given additional resources to enable the agency to undertake the
regulatory reviews associated with these new microbial products, or that Congress
amend the Toxic Substances Control Act (TSCA) to augment the regulatory
authority of the EPA in this arena. However, there was also strong agreement that
neither of these solutions was likely to be implemented in the short term. From a
synthetic biology product pipeline perspective, the regulatory burden may be
manageable for a few years.
New mechanisms for internal controls, codes, and practices may help
researchers, both from industry and academia, avoid a catastrophic, bad news
event, or other impediments to the continued development of synthetic biology.
This issue is of prime importance in the private sector. Protection of the process of
innovation by managing and communicating some of the risks in a proactive way
internally and externally to the public may actually avert a major public relations
crisis or reduce the need for direct government control. There seemed to be general
agreement that this suggestion would be a positive step for industry and academic
researchers.
In addition to the regulatory agencies, it was noted that many other agencies
that do not have regulatory authority may also play a role in the evaluation and
advancement of synthetic biology and related technologies. As to what these
agencies should be focusing on, one area readily identified was risk assessment,
especially the evaluation of whether the risk is based on scientifically credible
information and objective assessment. Another possible focus area was the
continued support of the basic scientific research that is ancillary to synthetic
biology, but is necessary to be able to bring good products to market. One such
area of basic research briefly discussed was the example of microbial ecology.
Performing risk assessments for synthetic organisms raised many issues. Over
several decades, studies have included gene transfer in soil samples from an
engineered microbe into strains that represent natural microbes, and direct testing
of kill switches in a variety of biosystems, including sea water and rats. There are
precedents for the types of experiments that lead to risk assessment of the biosafety
consequences, and there is already limited data that may be useful in assessing
risks for living cells. While it was agreed there is a body of literature in this area,
and that there is an understanding of some basic principles, there is still much that
is unknown, both from a scientific and policy perspective. As an example, it is still
unclear exactly what the EPA and the general public may consider adequate from
a risk assessment perspective. It was noted that the EPA has limited experience in
this type of work (approximately 35 to 40 cases), but that the USDA has considerably
more experience and expertise and thus may be a good resource for the EPA.
A question was raised, based on the current policy and governance framework,
as to what challenges the U.S. government faces related to synthetic biology
experiments and the ramifications of the technology, especially related to dual-

use. The example was of the potential development of a microbe that is accelerated
for environmental cleanup of oil spills, but which may also be used to wipe out
strategic petroleum deposits. It was acknowledged that, while the NIH and other
agency guidelines delineate requirements to consider, only a collaborative review
effort among a broad spectrum of scientific experience and thinking will result in
an effective evaluation of such experiments.
The ability to perform customer and sequence screening during the routine
course of work was acknowledged as a useful and reasonable undertaking. However,
this screening has the potential to be a significant bottleneck during a crisis situation,
such as an outbreak that occurs on a holiday or over the weekend. While this was
recognized as a challenge, advance communication, as well as requests coming
from known, legitimate sources, were offered as tools to mitigate this type of
situation.
The role of institutes and other stakeholders in bringing about regulatory
innovation in governments was discussed. The example of institutes working with
the FBI on security issues surrounding synthetic biology was noted as a successful
experiment, and the question was raised as to how this success could be replicated.
More institutes need to encourage and fund employees who consider the social
and political implications of their organizations research, and to work with
scientists. This type of engagement could come to be seen part of the responsibilities
of individual scientists, universities, industries, and research organizations.
Policy issues
Although synthetic biology is regulated by the same laws, regulations, and other
governance mechanisms that currently are applied to other biotechnology efforts,
it must be recognized that any emerging technology may pose novel and possibly
unique challenges to the existing regulatory framework. Policy makers must
appropriately address these challenges to meet five key societal concerns: biosecurity,
laboratory safety, harm to the environment, human health, and ethical issues. It is
critical that any new or modified regulation undertaken by policy makers also
considers the balance of these societal concerns with the potential and actual benefits
that may be produced through synthetic biology.
There is currently no jurisdiction over the voluntary assessment for
noncommercial microbes and the usefulness of such an assessment was discussed.
A key policy question concerns the anticipation of harm, as well as the audience or
user of the information that may be gathered. While there was no direct conclusion,
it was recognized that this proposed voluntary assessment was a minor suggestion
to fill a perceived gap.
The question remained whether synthetic biology is just biotechnology, or
something radically different, as it incorporates new concepts of life and opens
new paths of innovation. While the processes and methods are viewed as novel
and in some aspects unique, the products of synthetic biology are less novel and
can actually be largely identical to products generated by more traditional means.
However, plant biotechnology could possibly be entering a new stage in its
regulatory oversight, which may be triggered because, for historical reasons, the
existing regulations address the process rather than the product. Examples were
noted in both the U.S. and Europe of such regulation. It was stated that when
regulation focuses on process, a technology change, perhaps unintentionally,
requires a regulatory change. An important policy consideration was discussed as
to whether, even in the absence of increased risk, such changes in regulation were
beneficial, even though they were obviously necessary. It was concluded that
consideration of synthetic biology as just biotechnology may result in regulatory
flexibility with little or no increased risk.
The policy suggestion that the U.S. Department of Health and Human
Services (HHS) issue guidance for screening synthetic nucleotides to be directed
to providers of oligonucleotides (single-stranded nucleotides, from which
pathogenic viruses may be assembled), was debated. Oligonucleotide
manufacturers currently operate on such thin profit margins that it may be
problematic to require such order screening, which may bolster the argument for
outside funding of a screening database. However, even in a highly competitive
business environment, there are several regulatory burdens that are absorbed as
market conditions, if imposed evenly among all suppliers. It was noted that this
level playing field may inadvertently supply foreign oligonucleotide providers with
a competitive advantage.
The question was raised whether the FDA can rule on DNA-based or whole-
cell based therapeutics. One view was that any therapeutic agent that enters the
body, whether it is a whole cell to kill a tumor or DNA inserted into a cell, will be
appropriately regulated by the FDA. There was strong concurrence that this view
was correct. However, it was undecided whether the agency currently has the
appropriate skill sets and experience needed to regulate these products.
The difference between a synthetic biological and a product produced using
synthetic biology techniques was discussed. These two products could be regulated,
or at least considered, in different ways. The primary distinction noted was that, if
an end product is novel and different, the regulatory and perception hurdles would
naturally be higher. However, if a product is the same as an existing product, but
was produced in a less expensive or faster way, the current governance framework
may be more applicable. The example of generic drugs was offered, noting that if
a generic drug is sent to FDA for approval and bioequivalence is shown, it is approved
with little or no scrutiny applied to the process through which it was produced.
Acknowledgment
Numerous individuals and organizations have made important contributions to

the Institute on Science for Global Policy (ISGP) program on 21st Century Borders
(21CB). Some of these contributions directly supported the efforts needed to
organize the invitation-only ISGP conference on 21CB/Synthetic Biology (SB): Focus
on Responsibility and Governance convened in cooperation with the University of
Arizona at the El Conquistador Hotel and Resort in Tucson, Arizona, December
47, 2012. Other contributions aided the ISGP in preparing the material presented
in this book, including the eight policy position papers and the summary record,
without attribution, of the views presented in the discussions, critical debates, and
caucuses that ensued.
We would specifically like to thank our colleagues at the University of Arizona,
and especially Dr. Eugene Sander, former President, and Deans Shane Burgess
(College of Agriculture) and Joaquin Ruiz (College of Science) for their many,
critical contributions toward the success of this conference.
The ISGP greatly appreciates the willingness of those in the scientific and
policy communities to be interviewed by the ISGP staff, who organized the content
of this ISGP conference. The efforts of the scientific presenters with expertise in
SB invited by the ISGP to both prepare the eight policy position papers and engage
policy makers in the vigorous debates and caucuses that comprise all ISGP
conferences were especially appreciated. The biographies of these authors are
provided in this ISGP book
The success of every ISGP program critically depends on the active
engagement of all invited participants in the often-intense debates and caucuses.
The exchange of strongly held views, innovative proposals, and critiques generated
from questions and debates fosters an unusual, even unique, environment focused
on clarifying understanding for the nonspecialist by addressing specific questions
related to formulating and implementing effective public and private sector policies.
The ISGP is greatly indebted to all those who participated in these not-for-
attribution debates and caucuses.
The ISGP Board of Directors also deserves recognition for their time and
efforts in helping to create a vital and growing not-for-profit organization that has
relevance to many of the most important questions of our time. The current
membership of the ISGP Board of Directions and their brief biographical

backgrounds are presented at the end of this book.
The energetic, highly professional work of the ISGP staff merits special
acknowledgment. Their outstanding interviewing, organizing, and writing skills
were essential to not only convening the conference itself, but also to recording the
often-diverse views and perspectives expressed in the critical debates, capturing
the areas of consensus and actionable next steps from the caucuses, and persevering
through the extensive editing process needed to assure the accuracy of the material
published here. All of their work is gratefully acknowledged. Their biographies
are provided in this book.
ISGP programs are financially supported by government agencies and
departments and through gifts from private sector entities and philanthropic
individuals. Specifically, the ISGP conference in Tucson, Arizona, received funding
from the U.S. Department of Health and Human Services (HHS), the U.S.
Department of State (DOS), and the U.S. Department of Homeland Security (DHS)
under a work for others arrangement between the HHS and the ISGP. Financial
support from the National Intelligence Council (NIC), Federal Bureau of
Investigation (FBI), and the Istituto Regionale di Ricerca in Milan, Italy, was also
provided to the ISGP. The ISGP also benefited greatly from generous gifts provided
by the MARS Corp., Novartis, GlaxoSmithKline, and Mr. and Mrs. Edward Bessey.
Finally, the ISGP gratefully acknowledges the ongoing administrative support
provided by the Critical Path Institute.
Dr. George H. Atkinson
Founder and Executive Director
Institute on Science for Global Policy
January 29, 2013
ISGP books from previous ISGP conferences listed below are available to the
public and can be downloaded from the ISGP Web site:
www.scienceforglobalpolicy.org.
ISGP conferences on Emerging and Persistent Infectious Diseases:

EPID: Global Perspectives, convened Dec. 69, 2009 in Tucson, Arizona,
U.S.
EPID: Focus on Surveillance, convened Oct. 1720, 2010 in Warrenton,
Virginia, U.S.
EPID: Focus on Prevention, convened June 58, 2011 in San Diego,

California, U.S.
EPID: Focus on Mitigation, convened Oct. 2326, 2011 in Edinburgh,
Scotland, U.K. at the University of Edinburgh.
EPID: Focus on Societal and Economic Context. Convened July 8-11,
2012 in Fairfax, Virginia, U.S. at George Mason University
Biographical information of Scientific Presenters
Dr. Drew Endy, Ph.D.

Dr. Drew Endy is an Assistant Professor of Bioengineering at Stanford University.
He teaches in the new Bioengineering major at Stanford and previously helped
start the Biological Engineering major at MIT. His Stanford research team develops
genetically encoded computers and redesigns virus genomes. Dr. Endy co-founded
the BioBricks Foundation as a public-benefit charity supporting free-to-use
standards and technology that enable the engineering of biology. He co-organized
what has become the International Genetically Engineered Machines (iGEM)
competition and the BIOFAB: International Open Facility Advancing
Biotechnology (BIOFAB). Esquire magazine named Dr. Endy one of the 75 most
influential people of the 21st century. He serves on the U.S. Committee on Science
Technology and Law and is a new member of the National Science Advisory Board
for Biosecurity. He chaired the 2003 Synthetic Biology study as a member of the
DARPA Information Science and Technology Study Group. He has served as an
ad hoc member of the NIH Recombinant DNA Advisory Committee and co-
authored the 2007 Synthetic Genomics: Options for Governance report with
colleagues from the Center for Strategic and International Studies and the J. Craig
Venter Institute.
Ms. Leili Fatehi, J.D.

Ms. Leili Fatehi is a Research Fellow in the Science, Technology, and Environmental
Policy program area at the Hubert H. Humphrey School of Public Affairs at the
University of Minnesota. She is also an Adjunct Associate Professor of Law at the
University of Minnesota Law School. Her current research interests include the
legal, ethical, and policy dimensions of synthetic biology, genetics, and human
enhancement technologies. Ms. Fatehi has participated in several grants related to
issues of law and ethics in emerging sciences and technologies, including grants
from the National Science Foundation and National Institutes of Health. Prior to
joining to the Humphrey School, Ms. Fatehi was Associate Director of Research
and Education at the University of Minnesotas Consortium on Law and Values in
Health, Environment & the Life Sciences and Joint Degree Program in Law, Health
& the Life Sciences. From 2005-2007, Ms. Fatehi was a Research Associate at
Meridian Institute in Washington, D.C., where she researched and published on

the implications of nanotechnology for the worlds poor.
Prof. Paul Freemont, Ph.D.

Prof. Paul Freemont is cofounder and codirector of the Engineering and Physical
Sciences Research Council (ESPRC) Centre for Synthetic Biology and Innovation
at Imperial College London. Additionally, he is the Head of the Division of
Molecular Biosciences and Chair of Protein Crystallography at the university. He
previously was Director of the Centre for Structural Biology, also at Imperial College
London. His research on synthetic biology involves developing an engineering
framework and new technology platforms to enable synthetic biology research in
areas of bioenergy, biosensors, biomaterials, and metabolic engineering. He also
maintains an interest in understanding how disease-linked proteins work at the
molecular level. Prof. Freemont is a member of the CRUK Biological Sciences
funding committee including external five-year reviews, an external review member
of several UK Biosciences Departments, and a member of Biotechnology and
Biological Sciences Research Council pool of experts. Prof. Freemont has previously
been a member of the Wellcome Trust Genes Molecules and Cells panel, a member
of the Wellcome Trust fellowships panel, and a member of the Royal Academy of
Engineering Synthetic Biology inquiry. Prof. Freemont has published more than
140 peer-reviewed articles and has appeared regularly on radio and television
broadcasts on the subject of synthetic biology.
Dr. Robert Friedman, Ph.D.
Dr. Robert Friedman was recently appointed the Chief Operating Officer at the J.
Craig Venter Institute. Dr. Friedman also maintains his prior appointment as the
Deputy Director for California at the Venter Institute, where he directs the JCVI
Policy Center and is also active in several ongoing projects in the Institutes
Environmental Genomics Group. Prior to joining the Venter Institute, Dr. Friedman
was Vice President for Research at The Heinz Center, a nonprofit policy research
organization that brings together collaborators from government, industry,
environmental organizations, and academia. Earlier, Dr. Friedman was a Senior
Associate at the Office of Technology Assessment, U.S. Congress (OTA). For 16
years, he advised congressional committees on issues involving environmental and
natural resources policy. He is a Fellow of the American Association for the
Advancement of Science.
Prof. Eliot Herman, Ph.D.

Prof. Eliot Herman is Professor in the School of Plant Sciences at the University of
Arizona. Previously, he was Adjunct Professor in the Division of Plant Sciences at
the University of Missouri, a member of the Donald Danforth Plant Science Center,
and a Molecular Biologist with the U.S Department of Agriculture/ Agricultural
Research Service (USDA/ARS). Prof. Hermans research interests span the
disciplines of biochemistry, physiology, cell and developmental biology, genomics,
bioinformatics, and systems biology. Prof. Herman is a member of the American
Society of Plant Physiologists, the American Society for Biochemistry and Molecular
Biology, the Japanese Society of Plant Physiology, Sigma Xi, the American Society
for Cell Biology, and the American Society of Oil Chemists. He is on the Editorial
Board of PLANTA and, until 2012, was the Associate Editor for the Journal of
Experimental Botany. Prof. Herman has held visiting fellowships at the Weizmann
Institute in Israel, the Japanese Society for the Promotion of Science, and the U.S.
Embassy in Sweden. In 2004 he was awarded the Plow Honor Award by the U.S.
Secretary of Agriculture and in 2011 he was elected a Fellow of the American
Association for the Advancement of Science.
Dr. Todd Kuiken, Ph.D.

Dr. Todd Kuiken is a Senior Program Associate for the Synthetic Biology Program
at the Woodrow Wilson International Center for Scholars. In his current role, he
collaborates with DIYbio.org on a project to ensure safety within the rapidly
expanding community of amateur biologists and analyzes the potential biosecurity
threats associated with such a diffuse community. In addition, he has numerous
projects evaluating and designing new research and governance strategies to
proactively address the environmental risks associated with synthetic biology. He
also works with the Project on Emerging Nanotechnologies at the Woodrow Wilson
Center, where he focuses on the environmental health and safety, and public policy
aspects of nanotechnology. Dr. Kuiken previously worked at the Oak Ridge National
Laboratory, where he studied the biogeochemical cycling of mercury, and for various
environmental nonprofits. Dr. Kuiken is a regular speaker on public policy issues
related to nanotechnology and synthetic biology and has published a number of
articles on nanotechnology, synthetic biology, and mercury cycling.
Dr. Maria Mercedes Roca, Ph.D.
Maria Mercedes Roca is Associate Professor of Biotechnology at Zamorano
University, Honduras. Dr. Mercedes Roca joined Zamorano in 1997 as a lecturer
in plant pathology, following graduate studies in the United Kingdom. She holds
masters and doctoral degrees in plant pathology and virology from the University
of London, and a B.S. in microbiology from Kings College, London. Dr. Mercedes
Roca has worked as a faculty exchange member at the Norman Borlaug Institute at
Texas A&M University, and has organized conferences for the Caribbean Division
of the American Phytopathological Society, and the International Conference on

Agriculture and Environment. She is an adviser to the Honduran government on
agricultural biotechnology regulation, and was a member of the Honduran
delegation to the Rio+20 U.N. Conference on Sustainable Development in 2012.
Dr. Markus Schmidt, Ph.D.
Dr. Markus Schmidt is founder and CEO of Biofaction, a research, technology
assessment, and science communication company based in Vienna, Austria. He
has an educational background in electronic engineering (B.Sc.), biology (M.Sc.)
and environmental risk assessment (Ph.D.). Dr. Schmidt has carried out
environmental risk assessment, safety, and public perception studies in a number
of science and technology fields. Since 2005, he has pioneered synthetic biology
ethical, legal, and social implications (ELSI) research in Europe, being the principal
investigator and manager of the European Commission-funded project
SYNBIOSAFE, the first in Europe to look into the ethical, safety, security, and
governance aspects of synthetic biology. Dr. Schmidt has published extensively on
the societal aspects of synthetic biology, and edited and co-wrote two books about
the societal consequences of synthetic biology (2009) and its industrial and
environmental applications (2012). He served as an adviser to the European Group
on Ethics (EGE) of the European Commission and the U.S. Presidential
Commission for the Study of Bioethical Issues. In addition to his efforts in
technology assessment, he aims to contribute to a better interaction between science
and society through public talks, production of scientific documentary films, and
the organization of Science Film Festivals (Bio:fiction) and art-science exhibitions
(synth-ethic).
Dr. Amy Smithson, Ph.D.

Dr. Amy Smithson is a Senior Fellow at the James Martin Center for
Nonproliferation Studies and the co-chair of the Global Agenda Council on Nuclear,
Biological, and Chemical Weapons for the World Economic Forum. A specialist in
biological and chemical weapons nonproliferation, to reduce threats she often
recommends practical steps that blend technical and policy instruments and
fashions untraditional issue alliances that cross the private and public sectors and
international borders. She holds doctoral, masters, and bachelors degrees in
political science. Before joining CNS, Dr. Smithson worked at the Center for
Strategic and International Studies, the Henry L. Stimson Center, and Pacific-Sierra
Research Corporation. The author of numerous publications, including Germ
Gambits: The Bioweapons Dilemma, Iraq and Beyond (Stanford University Press,
2011), she has appeared frequently before Congress and in the electronic and print
media.
Biographical Information of ISGP Board of Directors
Dr. George Atkinson, Chairman

Dr. George Atkinson founded the Institute on Science for Global Policy (ISGP)
and is an Emeritus Professor of Chemistry, Biochemistry, and Optical Science at
the University of Arizona. He is former head of the Department of Chemistry at
the University of Arizona and the founder of a laser sensor company (Innovative
Lasers Corp.) serving the semiconductor industry. He also served in various
capacities in the U.S. federal government as an adviser for the use of science in
diplomacy, including as Science and Technology Adviser (STAS) to U.S. Secretaries
of State Colin Powell and Condoleezza Rice. He launched the ISGP in 2008 as a
new type of international forum in which credible experts provide governmental
and societal leaders with the objective understanding of the science and technology
that can be reasonably anticipated to help shape the increasingly global societies of
the 21st century. Dr. Atkinson has received National Science Foundation and
National Institutes of Health graduate fellowships, a National Academy of Sciences
Post Doctoral Fellowship, a Senior Fulbright Award, the SERC Award (U.K.), the
Senior Alexander von Humboldt Award (Germany), a Lady Davis Professorship
(Israel), the first American Institute of Physics Scientist Diplomat Award, a Titular
Directorship of the International Union of Pure and Applied Chemistry, the
Distinguished Service Award (Indiana University), an Honorary Doctorate (Eckerd
College), the Distinguished Achievement Award (University of California, Irvine),
and was selected by students as the Outstanding Teacher at the University of Arizona.
In 2013, he became the president-elect of the Sigma Xi Society. He received his
B.S. (high honors, Phi Beta Kappa) from Eckerd College and his Ph.D. in physical
chemistry from Indiana University.
Loretta Peto, Secretary/Treasurer

Loretta Peto is the founder and Managing Member at Peto & Company CPAs PLLC.
She has experience in: consulting on business valuation and litigation, including
valuing businesses for buy-sell agreements, estate and gift tax, marital dissolution
and employee compensation; consulting with closely held businesses regarding
business restructure, cash management, succession planning, performance
enhancement and business growth; and managing tax-related projects, including
specialty areas in corporate, partnership, estate and gift tax, business reorganizations,
and multistate tax reporting. She is a Certified Public Accountant and accredited
in Business Valuations. She is a member of the Finance Committee and Chair of
the Audit Committee at Tucson Regional Economic Opportunities. She also is a
member of the DM50 and Tucson Pima Arts Council. She received a Master of
Accounting - Emphasis in Taxation degree from the University of Arizona in 1984,
and was awarded the Outstanding Graduate Student Award.
Dr. Janet Bingham, Member

Dr. Janet Bingham has been President and CEO and a consultant to the Huntsman
Cancer Foundation (HCF) since 2006. The foundation is a charitable organization
that provides financial support to the Huntsman Cancer Institute, the largest cancer
specialty research center and hospital in the Intermountain West. Dr. Bingham
also has managed Huntsman Cancer Biotechnology Inc. In addition, she was
appointed Executive Vice President and Chief Operating Officer with the Huntsman
Foundation in 2008. The Huntsman Foundation is the private charitable foundation
established by Jon M. Huntsman Sr. to support education, cancer interests, programs
for abused women and children, and programs for the homeless. Before joining
the Huntsman philanthropic organizations, Dr. Bingham was the Vice President
for External Relations and Advancement at The University of Arizona. Prior to
her seven years in that post, she served as Assistant Vice President for Health Sciences
at The University of Arizona Health Sciences Center. Dr. Bingham was recognized
as one of the Ten Most Powerful Women in Arizona.
Dr. Henry Koffler, Member
Dr. Henry Koffler is President Emeritus of the University of Arizona (UA). He
served as President of the UA from 1982-1991. From 1982 he also held
professorships in the Departments of Biochemistry, Molecular and Cellular Biology,
and Microbiology and Immunology, positions from which he retired in 1997 as
Professor Emeritus of Biochemistry. His personal research during these years
concentrated on the physiology and molecular biology of microorganisms. He
was Vice President for Academic Affairs, University of Minnesota, and Chancellor,
University of Massachusetts/Amherst, before coming to the UA. He taught at
Purdue University, where he was a Hovde Distinguished Professor, and the School
of Medicine at Western Reserve University (now Case Western Reserve University).
Dr. Koffler served as a founding governor and founding vice-chairman of the
American Academy of Microbiology, and as a member of the governing boards of
Fermi National Accelerator Laboratory, the Argonne National Laboratory, and the
Superconducting Super Collider Laboratory. He was also a board member of the
Association of American Colleges and Universities, a member and chairman of
the Council of Presidents and a member of the executive committee of the National
Association of Land Grant Colleges and Universities. He was also Founder, President
and board member of The Arizona Senior Academy, the driving force in the
development of the Academy Village, an innovative living and learning community.
Among the honors that Dr. Koffler has received are a Guggenheim Fellowship and
the Eli Lilly Award in Bacteriology and Immunology.
Mr. Jim Kolbe, Member

For 22 years, Mr. Jim Kolbe served in the United States House of Representatives,
elected in Arizona for 11 consecutive terms, from 1985 to 2007. Mr. Kolbe is
currently serving as a Senior Transatlantic Fellow at the German Marshall Fund of
the United States, and as a Senior Adviser to McLarty Associates, a strategic
consulting firm. He advises on trade matters as well as issues of effectiveness of
U.S. assistance to foreign countries, on U.S.-E.U. relationships, and on migration
and its relationship to development. He is also co-chair of the Transatlantic
Taskforce on Development with Gunilla Carlsson, the Swedish Minister for
International Development Cooperation. He also is an adjunct Professor in the
College of Business at the University of Arizona. While in Congress, he served for
20 years on the Appropriations Committee of the House of Representatives, was
chairman of the Treasury, Post Office and Related Agencies subcommittee for four
years, and for his final six years in Congress, he chaired the Foreign Operations,
Export Financing and Related Agencies subcommittee. He graduated from
Northwestern University with a B.A. degree in Political Science and then from
Stanford University with an M.B.A. and a concentration in economics.
Dr. Charles Parmenter, Member

Dr. Charles Parmenter is a Distinguished Professor Emeritus of Chemistry at
Indiana University. He also served as Professor and Assistant and Associate Professor
at Indiana University in a career there that spanned nearly half a century (1964-
2010). He earned his bachelors degree from the University of Pennsylvania and
served as a Lieutenant in the U.S. Air Force from 1955-57. He worked at DuPont
after serving in the military and received his Ph.D. from the University of Rochester
and was a Postdoctoral Fellow at Harvard University. He has been elected a Member
of the National Academy of Sciences and the American Academy of Arts and
Sciences; and a Fellow of the American Physical Society and the American
Association for the Advancement of Science. He was a Guggenheim Fellow, a
Fulbright Senior Scholar, and received the Senior Alexander von Humboldt Award
in 1984. He has received the Earle K Plyler Prize, was a Spiers Medalist and Lecturer
at the Faraday Society, and served as Chair of the Division of Physical Chemistry
of the American Chemical Society, Co-Chair of the First Gordon Conference on

Molecular Energy Transfer, Co-organizer of the Telluride Workshop on Large
Amplitude Motion and Molecular Dynamics, and Councilor of Division of
Chemical Physics, American Physical Society.
Dr. Eugene Sander, Member
Dr. Eugene G. Sander served as the 20th president of the University of Arizona
(UA), stepping down in 2012. He formerly was vice provost and dean of the
universitys College of Agriculture and Life Sciences, overseeing 11 academic
departments and two schools, with research stations and offices throughout
Arizona. He also served as UA executive vice president and provost, vice president
for University Outreach and director of the Agricultural Experiment Station and
acting director of Cooperative Extension Service. Prior to his move to Arizona,
Sander served as the deputy chancellor for biotechnology development, director
of the Institute of Biosciences and Technology, and head of the department of
biochemistry and biophysics for the Texas A&M University system. He was chairman
of the department of biochemistry at West Virginia University Medical Center and
associate chairman of the department of biochemistry and molecular biology at
the College of Medicine, University of Florida. As an officer in the United States
Air Force, he was the assistant chief of the biospecialties section at the Aerospace
Medical Research Laboratory. He graduated with a bachelors degree from the
University of Minnesota, received his masters degree and Ph.D. from Cornell
University and completed postdoctoral study at Brandeis University. As a
biochemist, Sander worked in the field of mechanisms by which enzymes catalyze
reactions.
Biographical information of ISGP staff
Dr. George Atkinson, Executive Director

Dr. George Atkinson is the founder and Executive Director of the Institute on
Science for Global Policy (ISGP) and is an Emeritus Professor of Chemistry,
Biochemistry, and Optical Science at the University of Arizona. His professional
career has involved academic teaching, research, and administration, roles as a
corporate founder and executive, and public service at the federal level. He is former
Head of the Department of Chemistry at the University of Arizona, the founder of
a laser sensor company serving the semiconductor industry, and Science and
Technology Adviser (STAS) to U.S. Secretaries of State Colin Powell and
Condoleezza Rice. In 2013, he became the president-elect of the Sigma Xi Society.
Based on principles derived from his personal experiences, he launched the ISGP
in 2008 as a new type of international forum in which credible experts provide
governmental and societal leaders with the objective understanding of the science
and technology that can be reasonably anticipated to help shape the increasingly
global societies of the 21st century.
Jennifer Boice, M.B.A.

Jennifer Boice is the Program Coordinator of the ISGP. Ms. Boice worked for 25
years in the newspaper industry, primarily at the Tucson Citizen and briefly at
USAToday. She was the Editor of the Tucson Citizen when it was closed in 2009.
Additional appointments at the Tucson Citizen included Business News Editor,
Editor of the Online Department, and Senior Editor. She also was a business
columnist. Ms. Boice received an M.B.A. from the University of Arizona and
graduated from Pomona College in California with a degree in economics.
Melanie Brickman Stynes, Ph.D., M.Sc.

Melanie Brickman Stynes is Associate Director with the ISGP. As a researcher
focused on the juncture of public health, demography, policy, and geography, she
bridges multiple fields in her emerging and persistent infectious diseases research.
Her work has paid particular attention to issues surrounding tuberculosis control
(historic and contemporary). She is also an Adjunct Professor at Baruch Colleges
School of Public Affairs in New York City. Additionally, Dr. Brickman Stynes spent
nearly a decade as a Research Associate for the Center for International Earth Science
Information Network (CIESIN) of Columbia University, where she worked on a

range of projects related to health, disease, poverty, urbanization, and population
issues. She received her Ph.D. in medical geography from University College London
and her M.Sc. in medical demography from the London School of Hygiene and
Tropical Medicine.
Sweta Chakraborty, Ph.D.
Sweta Chakraborty is a Senior Fellow with the ISGP. She recently completed post-
doctoral research on pharmaceutical regulation and product liability at Oxford
Universitys Centre for Socio-Legal Studies and remains an active member of
Wolfson College. Dr. Chakraborty received her doctorate in Risk Management
from Kings College London and has helped to design and co-teach a summer
course in London on Managing Hazards in Europe and the United States with
Indiana Universitys School of Public and Environmental Affairs. Her undergraduate
degrees are in Decision Science and International Relations from Carnegie Mellon
University.
Anna Isaacs, M.Sc.

Anna Isaacs is a Senior Fellow with the ISGP. She has previously focused on minority
health issues and is experienced in field and desk-based qualitative research. She
has interned as a researcher at a variety of nonprofit institutions and also at the
House of Commons in London. Ms. Isaacs received her M.Sc. with distinction in
Medical Anthropology from University College London and a B.Sc. in Political
Science from the University of Bristol.
Paul Lewis, J.D.

Paul Lewis is a Fellow with the ISGP. He worked as a Congressional Aide in
Washington, D.C., and as a Legal Associate specializing in Federal Immigration
Law before working with Google on Maps and Local Search products. Mr. Lewis
came to Google through Immersive Media, the company behind Street View camera
technology. He was involved in the rollout of Google Street View, and has managed
projects involving 360-degree GPS embedded data worldwide. Mr. Lewis earned
his Juris Doctor at the University of Arizona and graduated Magna Cum Laude
with degrees in Journalism and Political Science from Northern Arizona University.
Harvey Morris, Ph.D.

Harvey Morris is a Fellow with the ISGP. As a Licensed Psychologist he began his
work on staff at the New York Health and Hospitals Corporation, and eventually
became Director of Clinical Services at a private 100-bed hospital. In the late 1970s
he founded and managed a mid-sized specialty consulting firm that assisted major
global corporations and national governmental agencies in accelerating strategy

implementation. After retiring, he founded and served as Executive Director of a
not-for-profit foundation, and served on an advisory board at the University of
Arizona. Dr. Morris received a B.A. in Psychology from the City University of New
York, and a Ph.D. in Clinical Psychology from the University of Nebraska.
David Miller, M.B.A.
David Miller is a Scientific/Program Consultant with the ISGP. Previously, he was
Director, Medical Advocacy, Policy and Patient Programs at GlaxoSmithKline, where
he led the companys U.S. efforts relating to science policy. In this role, he advised
senior management on policy issues, and was the primary liaison between the
company and the national trade associations, Pharmaceutical Research and
Manufacturers of America (PhRMA) and Biotechnology Industry Organization
(BIO). He also held management positions in business development and quality
assurance operations. Mr. Miller received his B.S. in Chemistry and his M.B.A.
from the University of North Carolina at Chapel Hill.
Sara Pistolesi, Ph.D.

Dr. Sara Pistolesi is a Fellow with the ISGP and a postdoctoral research fellow at
the National Heart, Lung, and Blood Institute, National Institutes of Health in
Bethesda, Maryland. Her research involves investigating the function of several
protein complexes involved in key cellular processes using Nuclear Magnetic
Resonance. Prior to this, she worked as a postdoctoral researcher at the University
of Siena, Italy, where she also earned her Laurea (B.S.+M.S.) in pure Chemistry
and her Ph.D. in Chemical Sciences. Dr. Pistolesi is also a freelance editor for
Cactus Communications for which she helps non-native English-speaking scientists
to publish their work in internationally recognized peer-reviewed journals by
revising their manuscripts. Additionally, Dr. Pistolesi served as chemistry judge
and special award judge for the Biophysical Society at science fairs at county and
government level.
Arthur Rotstein, M.S.J.

Arthur Rotstein is Copy Editor with the ISGP. Prior to joining the ISGP, Mr. Rotstein
worked for the Washington D.C. Daily News, held a fellowship at the University of
Chicago, and spent more than 35 years working as a journalist with The Associated
Press. His writings have covered diverse topics that include politics, immigration,
border issues, heart transplant and artificial heart developments, Biosphere 2, college
athletics, features, papal visits, and the Mexico City earthquake. Mr. Rotstein holds
a M.S.J. from Northwestern Universitys Medill School of Journalism.
Raymond Schmidt, Ph.D.

Ray Schmidt is a Senior Fellow with the ISGP. In addition, he is a physical chemist/
chemical engineer with a strong interest in organizational effectiveness and
community health care outcomes. While teaching at the university level, his research
focused on using laser light scattering to study liquids, polymer flow, and biological
transport phenomena. Upon moving to the upstream petroleum industry, he
concentrated on research and development (R&D) and leading multidisciplinary
teams from numerous companies to investigate future enhanced oil recovery ideas
and to pilot/commercialize innovative recovery methods in domestic and foreign
locations. Dr. Schmidt received his Ph.D. in chemistry from Emory University.
Ramiro Soto
Ramiro Soto is a Fellow at the ISGP. He currently is an undergraduate student at
the University of Arizona College of Science seeking a Bachelor of Science degree
in General Applied Mathematics. Beyond his academic curriculum, Mr. Soto is an
active member of the Pride of Arizona marching band since 2010 and recently
became a member of the athletic pep band. He completed an internship with the
Walt Disney Company Parks and Resorts segment in 2011. After completing his
undergraduate education, he plans to apply for a doctoral program furthering his
studies in mathematics.
Matt Wenham, D.Phil.

Matt Wenham is Associate Director with the ISGP. He formerly was a postdoctoral
research fellow at the National Institutes of Health in Bethesda, Maryland. His
research involved studying the interaction of protein toxins produced by pathogenic
E. coli strains with human cells. Dr. Wenham received his D. Phil. from the Sir
William Dunn School of Pathology, University of Oxford, United Kingdom, where
he was a Rhodes Scholar. Prior to this, he worked in research positions at universities
in Adelaide and Melbourne, Australia. Dr. Wenham received his bachelors and
honours degrees in biochemistry from the University of Adelaide, South Australia,
and holds a Graduate Diploma of Education from Monash University, Victoria.

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Social science Engineering Framework

Institute on Science for Global Policy (ISGP)

Risk-benefit Media Public Synthetic Biology

Genetic Governance Regulation Voluntary

Anticipatory Databases Xenobiology

21st Century Borders/Synthetic Biology:

Conference convened by the ISGP Dec. 47, 2012

Risk Technology Oversight Plants

Genetically modified Protein Standards

21st Century Borders/Synthetic Biology:

Conference convened by the ISGP in partnership with

An ongoing series of dialogues and critical debates

Policy position papers and debate summaries

Synthetic Biology Do We Need New Regulatory Systems?

The Challenges of Deploying Synthetic Biology Technologies

The Challenge To Meet Global Need For Protein Sources

Safeguarding the Genetic Firewall with Xenobiology

Policy Innovation in Synthetic Biology Governance

Do-It-Yourself Biology: Reality and the Path Toward Innovation

The ISGP mission

ISGP programs rely on the validity of two overarching principles:

ISGP conference structure

Actionable Next Steps

resistance. Synthetic biology enables scientists to focus on other important societal

Actionable Next Steps

Actionable Next Steps

Establish international forums for articulating the concerns of less-affluent

Actionable Next Steps

Actionable Next Steps

methods are not inherently more risky than those introduced by

ISGP conference program

Presentations and Debates: Session 1

16:30 18:00 Prof. Eliot Herman, School of Plant Sciences,

Synthetic Biology Do We Need New

Scientific opportunities and challenges

protein-based bioproducts (e.g., enzymes), medical applications (e.g., biosensors,

biological material formally registered (locally) and approved before

Scientific opportunities and challenges

concerning how to extend such involvement to a societal, legal, or ethical issues

Renovating Governance Strategies for Synthetic Biology

Scientific opportunities and challenges

applicable to other sensitive technologies, equipment, and materials. For

Ongoing discussions concerning oversight and regulations of specific

private sector considers self-imposed regulation (e.g., screening customers and

Scientific opportunities and challenges

already have detailed databases of potentially unsafe practitioners. These databases

While government and academia may not be well positioned to innovate

The Challenges of Deploying Synthetic Biology

Scientific opportunities and challenges

intellectual property (IP), biosecurity, biosafety, and ethics, and a categorization

The promise and excitement of synthetic biology as a new technology, driven

Scientific opportunities and challenges

the public interest and is not driven by individual organizations. Alternative

The Challenge to Meet Global Need for

Scientific opportunities and challenges

regions currently dominated by cereal production and/or be able to tolerate the

establishing one or more international centers encompassing terrestrial

The preliminary indications that plants engineered via synthetic biology

Scientific opportunities and challenges

could be used as a soybean proxy in providing protein-rich animal feed. Camelina

difficult to achieve because of the dominance of consumerism and overabundance

Safeguarding the Genetic Firewall with Xenobiology**

Scientific opportunities and challenges